Bivona 67PFP50: a 5.0 mm pediatric TTS tracheostomy tube, FlexTend Plus, “V” neck flange
Reference 67PFP50 is the Bivona TTS Pediatric FlexTend Plus tracheostomy tube with a “V” neck flange, in the 5.0 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.The Bivona 67PFP50 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 5.0 mm inner diameter, 7.3 mm outer diameter, 50.0 mm distal length, 30.0 mm proximal length, a 120° angle and a cuff resting diameter of 5.3 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 6084945, with an expiration date of January 8, 2030.
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
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 5.3 mm. The manufacturer publishes no fixed inflation volume.
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.
5.0 mm inner diameter, 7.3 mm outer diameter, 50.0 mm distal length, 30.0 mm proximal length and a 120° angle — the figures in the manufacturer’s own catalog row for 67PFP50.
Radiopaque silicone in the manufacturer’s SuperSlick™ formulation, free of DEHP, latex and plasticizers, with wire-reinforced proximal and distal sections.
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.
This reference is subject to an open FDA Class I recall (Z-2611-2024) that covers specific lots. Our units are from lot 6084945, which is not among the lots the FDA lists as affected, and they expire on January 8, 2030. We checked the lot on September 16, 2026, and we’ll send you a photo of the label if you ask.
What the code 67PFP50 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) |
| 50 | 5.0 mm inner diameter |
The FDA labels this same reference “Pediatric Tracheostomy Tube 5.0 mm TTS FlexTend Plus V Flange”, which matches the catalog reading above.
Details
Verified specifications
| Manufacturer reference | 67PFP50 |
| 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.) | 5.0 mm |
| Outer diameter (O.D.) | 7.3 mm |
| Distal length (intratracheal) | 50.0 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 | 5.3 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 |
| Latex | Latex free: the sterile pouch carries the crossed-out latex symbol |
| Label schematic dimensions (A / B / C) | A 16.9 mm · B 0 mm · C 33.1 mm · 120° — as printed on the manufacturer’s label schematic |
| MRI | MR Conditional |
| UDI-DI (GTIN) | 10351688518514 |
| 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 of the units in stock | 6084945 |
| Manufacturing date | 2025-01-09 |
| Expiration date | 2030-01-08 |
| 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 of the units we have in stock (lot, dates, origin, sterilization, latex symbol 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 (5.3 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 units are from lot 6084945, manufactured on January 9, 2025, with an expiration date of January 8, 2030. The box label states they are 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:
- 67PFP50 — FlexTend Plus, “V” neck flange. This is the reference on this page.
- 67PFS50 — FlexTend without Plus, “V” neck flange.
- 67PFPS50 — FlexTend Plus, straight neck flange.
Some retailers title 67PFP50 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?
Do I need a prescription?
What do “5.0” and “50 mm” refer to?
What is the overall length?
How is the TTS cuff inflated?
What is the difference between 67PFP50, 67PFS50 and 67PFPS50?
Does it include an inner cannula?
How do I know which size is needed?
Is it safe in an MRI?
Can it be cleaned and reused, or re-sterilized?
Is it FDA approved?
Is it latex free?
Does it have an expiration date?
Do you carry other sizes or other Bivona references?
How does it ship?
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.

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