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Provox LaryTube 12/55 with Ring

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox LaryTube 12/55 with Ring FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. FDA UDI
Model / Reference
7631 FDA UDI
Description
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. FDA UDI

Identifiers

Catalog Number
7631 FDA UDI
Primary DI / UDI-DI
07331791002458 FDA UDI
FDA Product Code
KAC FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 13.5 Millimeter FDA UDI
Outer Diameter — 17.0 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

Provox LaryTube 12/55 with Ring by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI bc9c40b7-f890-44a1-99c4-2966c4c49f65 37 fields · synced Jun 1, 2026