Identity
- Trade Name
- Provox TubeHolder FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Provox TubeHolder is used for extra support for Provox LaryButton and Provox LaryTube. It goes around the neck of the user and the ends are attached to the “ears” of the LaryTube/LaryButton. The Tubeholder is adjustable in length using a Velcro® connection and allows the user to cut the band to suitable length. FDA UDI
- Model / Reference
- 7668 FDA UDI
- Description
- Provox TubeHolder is used for extra support for Provox LaryButton and Provox LaryTube. It goes around the neck of the user and the ends are attached to the “ears” of the LaryTube/LaryButton. The Tubeholder is adjustable in length using a Velcro® connection and allows the user to cut the band to suitable length. FDA UDI
Identifiers
- Catalog Number
- 7668 FDA UDI
- Primary DI / UDI-DI
- 07331791002670 FDA UDI
- FDA Product Code
- CBH FDA UDI
- GMDN Term
- Tracheostomy tube neck holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Category: Tracheostomy tube neck holder, single-use
Provox TubeHolder by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 5d53784d-99f7-473e-8f15-70209cfffb35 36 fields · synced May 30, 2026