Bivona 67PFP45 pediatric FlexTend Plus TTS silicone tracheostomy tube, 4.5 mm ID, front of the box with product label (Portex, Smiths Medical)

Back of the Bivona 67PFP45 pediatric silicone tracheostomy tube box (4.5 mm) with the product name in multiple languages

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Bivona TTS Pediatric Tracheostomy Tube 4.5 mm, FlexTend Plus, V Neck Flange (67PFP45)

Q: What do “4.5” and “48 mm” refer to?

They are two different measurements. 4.5 mm is the inner diameter of the tube, the size in the reference code (the “45”). 48.0 mm is the distal length — the portion that sits inside the trachea — and it is the “Length: 48 mm” printed on the box label. The proximal FlexTend Plus extension, outside the flange, is a separate 30.0 mm.

Q: What is the difference between 67PFP45, 67PFS45 and 67PFPS45?

67PFP45 is FlexTend Plus with a “V” neck flange — the reference on this page. 67PFS45 is FlexTend without Plus, with a “V” flange. 67PFPS45 is FlexTend Plus with a straight flange. Check the code printed on the box against the one you were given.

Q: Is it safe in an MRI?

It is MR Conditional, confirmed by both the manufacturer’s catalog and the FDA device registry. That means it is safe only under specified scanning conditions. The specific conditions for this pediatric reference are not published in the documents we have, so we don’t state them here: give the reference and the instructions in the box to the imaging facility before any scan.

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Genuine Bivona TTS Pediatric FlexTend Plus tracheostomy tube, reference 67PFP45
4.5 mm inner diameter · 6.7 mm outer diameter · 48.0 mm distal length · 120° angle
TTS (Tight-To-Shaft) silicone cuff · FlexTend Plus 30.0 mm proximal extension · “V” neck flange
Radiopaque SuperSlick™ silicone, free of DEHP, latex and plasticizers · MR Conditional
New and sterile (EO), one per package, with obturator, disconnection wedge and twill tape · made in Mexico
Lot 6084944, expires 2030-01-20 · prescription required: upload it at checkout or after your purchase

Genuine Bivona TTS Pediatric FlexTend Plus tracheostomy tube, reference 67PFP45
4.5 mm inner diameter · 6.7 mm outer diameter · 48.0 mm distal length · 120° angle
TTS (Tight-To-Shaft) silicone cuff · FlexTend Plus 30.0 mm proximal extension · “V” neck flange
Radiopaque SuperSlick™ silicone, free of DEHP, latex and plasticizers · MR Conditional
New and sterile (EO), one per package, with obturator, disconnection wedge and twill tape · made in Mexico
Lot 6084944, expires 2030-01-20 · prescription required: upload it at checkout or after your purchase

Genuine productFree shipping on orders $99+Ships from Miami, FLExpert help · (786) 755-8063

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VISAAMEXDISC●VER Affirm

Brand: Bivona
SKU: 67PFP45
Category: Tracheostomy

Description
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NEW · STERILE, SEALED PACKAGE · 4.5 MM I.D. · PRESCRIPTION REQUIRED

Bivona 67PFP45: a 4.5 mm pediatric TTS tracheostomy tube, FlexTend Plus, “V” neck flange

Reference 67PFP45 is the Bivona TTS Pediatric FlexTend Plus tracheostomy tube with a “V” neck flange, in the 4.5 mm inner diameter size. It is a cuffed silicone tube: the TTS (Tight-To-Shaft) cuff lies flat against the shaft when deflated. The FlexTend Plus extension adds 30.0 mm of wire-reinforced tubing outside the flange, which carries the integral 15 mm connector away from the neck. Each tube is supplied sterile, one per package, with an obturator, a disconnection wedge and twill tape.

Genuine Bivona product, made by Smiths Medical ASD, Inc., now ICU Medical, Inc. · new, sterile, in its sealed package · 510(k) authorization, Class II (21 CFR 868.5800) · prescription required · ships from Doral, FL.

In short

The Bivona 67PFP45 is a pediatric tracheostomy tube in radiopaque SuperSlick™ silicone with a TTS (Tight-To-Shaft) cuff, the FlexTend Plus proximal extension and a “V” neck flange. The manufacturer’s figures for this reference are 4.5 mm inner diameter, 6.7 mm outer diameter, 48.0 mm distal length, 30.0 mm proximal length, a 120° angle and a cuff resting diameter of 4.7 mm. The manufacturer does not publish an overall length, and does not size these tubes by age or weight: the physician specifies the inner diameter and the length. Each package holds one tube, supplied sterile, with an obturator, a disconnection wedge and twill tape. It is free of DEHP, latex and plasticizers, is MR Conditional and is a prescription device. American Oxygen sells this reference new and sterile, in its sealed package, from lot 6084944, with an expiration date of January 20, 2030.

Prescription required

Prescription required: upload it at checkout or after your purchase. A photo or a PDF of the prescription is enough, and it goes straight to our team. If you have a question about the reference, call or message us on WhatsApp.

What this reference gives you

TTS cuff, flat when deflated

The silicone Tight-To-Shaft cuff lies flat against the shaft when it is deflated, so it adds little to the tube’s profile. Its resting diameter is 4.7 mm. The manufacturer publishes no fixed inflation volume.

FlexTend Plus extension, 30.0 mm

Thirty millimetres of wire-reinforced tubing proximal to the flange, so the integral 15 mm connector sits away from the neck and the chin. FlexTend Plus also adds distal length.

Dimensions from the manufacturer’s catalog

4.5 mm inner diameter, 6.7 mm outer diameter, 48.0 mm distal length, 30.0 mm proximal length and a 120° angle — the figures in the manufacturer’s own catalog row for 67PFP45.

Radiopaque SuperSlick™ silicone

Radiopaque silicone in the manufacturer’s SuperSlick™ formulation, free of DEHP, latex and plasticizers, with wire-reinforced proximal and distal sections.

One tube per package, sterile

Each package holds one tube, supplied sterile, together with an obturator, a disconnection wedge and twill tape. The manufacturer’s catalog does not list an inner cannula for this reference.

Lot checked against the FDA record

This reference is subject to an open FDA Class I recall (Z-2611-2024) that covers specific lots. Our stock is from lot 6084944, which is not among the lots the FDA lists as affected, and it expires on January 20, 2030. We checked the lot on September 17, 2026, and we’ll send you a photo of the label if you ask.

What the code 67PFP45 means

Bivona references are read segment by segment. Two neighbouring codes differ by a single letter and are different products.

Segment	Reads as
67	TTS series, with cuff (a 60 prefix is cuffless)
P	Pediatric (an N is neonatal)
F	FlexTend proximal extension
P	Plus
no final S	“V” neck flange (a final S is a straight flange)
45	4.5 mm inner diameter (the sister reference 67PFP50 is 5.0 mm)

The FDA labels this same reference “Pediatric Tracheostomy Tube 4.5 mm TTS FlexTend Plus V Flange”, which matches the catalog reading above.

Details

Verified specifications

Manufacturer reference	67PFP45
Product name	Bivona TTS Pediatric FlexTend Plus Tracheostomy Tube (Cuff “V” Neck Flange)
Brand / manufacturer	Bivona — Smiths Medical ASD, Inc., now ICU Medical, Inc.
Patient range	Pediatric
Inner diameter (I.D.)	4.5 mm
Outer diameter (O.D.)	6.7 mm
Distal length (intratracheal)	48.0 mm
Proximal length (FlexTend Plus extension)	30.0 mm
Overall length	The manufacturer publishes the two lengths above and does not publish an overall length
Tube angle	120°
Cuff	Yes — TTS (Tight-To-Shaft) silicone cuff; lies flat against the shaft when deflated
Cuff resting diameter	4.7 mm (a diameter, not a volume)
Cuff inflation	To the volume set by the clinician. The manufacturer’s pediatric handbook indicates sterile water, not air, when the cuff stays inflated for more than 2 hours
Neck flange	“V” shape
FlexTend	FlexTend Plus — wire-reinforced proximal extension, with additional distal length
15 mm connector	Integral
Inner cannula	Not listed in the manufacturer’s catalog for this reference
Material	Radiopaque silicone, SuperSlick™ formulation
DEHP, latex, plasticizers	Free of DEHP, latex and plasticizers
Reinforcement	Wire reinforced, proximal and distal sections
Supplied with each tube	Obturator, disconnection wedge and twill tape
Units per package	1 (per the box label)
Sterility	Sterile, ethylene oxide (STERILE EO); no sterilization before use
Label schematic dimensions (A / B / C)	A 16.2 mm · B 0 mm · C 31.8 mm · 120° — as printed on the manufacturer’s label schematic
MRI	MR Conditional
UDI-DI (GTIN)	10351688518507
FDA status	510(k) authorization, Class II (21 CFR 868.5800)
Prescription	Required (Rx only) — upload it at checkout or after your purchase
Use environment	Hospital and home
Condition	New, sterile, in its sealed package
Lot in stock	6084944
Manufacturing date	2025-01-21
Expiration date	2030-01-20
Country of origin	Made in Mexico
Shipping	Ships from Doral, FL

Figures come from the manufacturer’s Bivona silicone tracheostomy tube catalog, from the FDA device registry entry for this reference, from the manufacturer’s neonatal and pediatric handbook where noted, and from the label on the box we have in stock (lot, dates, origin and the A/B/C schematic dimensions).

What comes in the package

One tube per package, supplied sterile. The manufacturer states that each tube is individually packaged with an obturator, a disconnection wedge and twill tape.

The manufacturer’s catalog does not list an inner cannula for this reference. If an inner cannula matters to you, call or message us on WhatsApp and we’ll confirm what the package in front of us contains.

The TTS cuff: what the manufacturer states about inflation

The TTS cuff is made of silicone, and silicone is permeable to air, so a cuff inflated with air deflates slowly on its own. The manufacturer’s neonatal and pediatric handbook states that, when the TTS cuff is to stay inflated for more than two hours, the manufacturer specifies sterile water rather than air, using a 10 cc syringe and purging the residual air. The procedure is directed by the clinical team.

There is no fixed volume. The manufacturer publishes the cuff’s resting diameter (4.7 mm) and states that the cuff is inflated to the volume prescribed by the clinician. The clinical team sets that volume, not us.

Condition, sterility and lot

New. The tube is supplied sterile, sterilized with ethylene oxide, in its sealed package, and the manufacturer’s registry entry confirms it needs no sterilization before use. Sterility depends on the package being intact: if a package were open or damaged, the product would not be sold as sterile.

Lot and expiration. Both are printed on the box. Our stock is from lot 6084944, manufactured on January 21, 2025, with an expiration date of January 20, 2030. The box label states it is made in Mexico. Ask us and we’ll send you a photo of the label on the unit that would ship to you.

American Oxygen sells genuine Bivona product. We are not an authorized Bivona, Smiths Medical or ICU Medical distributor, and there is no manufacturer warranty attached to this sale.

References that look similar but are not this one

Three codes sit close together in the manufacturer’s tables and are often confused. They are different products:

67PFP45 — FlexTend Plus, “V” neck flange. This is the reference on this page.
67PFS45 — FlexTend without Plus, “V” neck flange.
67PFPS45 — FlexTend Plus, straight neck flange.

Some listings title these references simply as “FlexTend TTS”, dropping the word Plus. The code itself is unambiguous: read the reference printed on the box, not the title on the listing.

Frequently asked questions

Is this reference subject to an FDA recall?

Yes, by lot. Since May 2024 the manufacturer has been removing specific lots of several Bivona neonatal and pediatric references, 67PFP45 among them, because the securement flange can tear. The FDA classified it as a Class I recall, its most serious category, and it remains open. The recall covers listed lot numbers, not the reference as a whole, and the FDA lists 12 affected lots for 67PFP45, all of them earlier than ours. Our stock is from lot 6084944, which is not on that list — we checked it against the FDA’s own recall record on September 17, 2026. This lot expires on January 20, 2030. If you’d like to see it for yourself, ask us and we’ll send you a photo of the box label with the lot number and the expiration date.

Do I need a prescription?

Yes. This is a prescription device: federal law restricts it to sale by or on the order of a licensed practitioner. Prescription required: upload it at checkout or after your purchase, with the “Upload your prescription” button on this page or the one in checkout. A photo or a PDF is enough. If you have a question, call or message us on WhatsApp.

What do “4.5” and “48 mm” refer to?

They are two different measurements. 4.5 mm is the inner diameter of the tube, the size in the reference code (the “45”). 48.0 mm is the distal length — the portion that sits inside the trachea — and it is the “Length: 48 mm” printed on the box label. The proximal FlexTend Plus extension, outside the flange, is a separate 30.0 mm.

What is the overall length?

The manufacturer does not publish one. It publishes the distal length (48.0 mm) and the proximal length (30.0 mm) as separate figures. Some distributor listings show an “overall length” for these tubes; those figures do not come from the manufacturer and we don’t publish them.

How is the TTS cuff inflated?

To the volume set by the clinician — the manufacturer publishes no fixed volume, only the cuff’s resting diameter of 4.7 mm. Its neonatal and pediatric handbook indicates that when the cuff is to stay inflated for more than two hours, it should be inflated with sterile water rather than air, using a 10 cc syringe and purging the residual air, because silicone is permeable to air.

What is the difference between 67PFP45, 67PFS45 and 67PFPS45?

67PFP45 is FlexTend Plus with a “V” neck flange — the reference on this page. 67PFS45 is FlexTend without Plus, with a “V” flange. 67PFPS45 is FlexTend Plus with a straight flange. Check the code printed on the box against the one you were given.

Does it include an inner cannula?

The manufacturer’s catalog lists each tube as individually packaged with an obturator, a disconnection wedge and twill tape. It does not list an inner cannula for this reference. If that point is decisive for you, call us and we’ll confirm the contents of the package we have.

How do I know which size is needed?

The physician specifies it. The manufacturer sizes these tubes by two measurements — inner diameter and length — and publishes no sizing by age or by weight. American Oxygen does not recommend a size and does not give clinical advice. Order the reference your prescribing physician specifies.

Is it safe in an MRI?

It is MR Conditional, confirmed by both the manufacturer’s catalog and the FDA device registry. That means it is safe only under specified scanning conditions. The specific conditions for this pediatric reference are not published in the documents we have, so we don’t state them here: give the reference and the instructions in the box to the imaging facility before any scan.

Can it be cleaned and reused, or re-sterilized?

We sell it new and sterile, in its sealed package, and that is the condition we stand behind. The manufacturer’s device registry entry marks this reference as single use, while its catalog describes sanitization of silicone tubes — two statements we are not going to reconcile on your behalf. We make no reuse or re-sterilization claim. Follow the instructions that come with the device and your clinical team.

Is it FDA approved?

“Approved” is not the right word for this class of device. Tracheostomy tubes of this type reach the U.S. market through the FDA’s 510(k) authorization pathway as Class II devices under 21 CFR 868.5800 — a different route from FDA approval. This reference remains in commercial distribution in the manufacturer’s registry entry.

Is it latex free?

Yes. The manufacturer states that these silicone tubes are free of DEHP, latex and plasticizers.

Does it have an expiration date?

Yes. Our stock expires on January 20, 2030 (lot 6084944, manufactured on January 21, 2025). Both dates are printed on the box; ask us and we’ll send you a photo of the label on the unit that would ship to you.

Do you carry other sizes or other Bivona references?

Yes. We also list the sister reference Bivona 67PFP50: the same TTS FlexTend Plus tube with a “V” neck flange, in the 5.0 mm inner diameter size. We hold other Bivona references that are not published yet, so if you need a different inner diameter or configuration, call or message us and we’ll tell you what we actually have. You can also browse our tracheostomy category. The size itself is the one your physician specifies.

How does it ship?

Shipping is free anywhere in the U.S. — it ships from our store in Doral, FL. If you’re in the Miami area, choose Store pickup (Doral, FL) at checkout and collect it yourself at no cost. For destinations outside the U.S., the cost is shown at checkout based on your address.

Questions about this reference?

Prescription required: upload it at checkout or after your purchase. For anything else, call or message us on WhatsApp: we’ll read you the label, send you a photo of the lot number and the expiration date, and confirm exactly what the package contains.

Call (786) 755-8063 WhatsApp us

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