Identity
- Trade Name
- Provox StabiliBase (15 pcs) FDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas. FDA UDI
- Model / Reference
- 7289 FDA UDI
- Description
- Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas. FDA UDI
Identifiers
- Catalog Number
- 7289 FDA UDI
- Primary DI / UDI-DI
- 07331791008016 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Removable ambulatory appliance skin-adherent patch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 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: Removable ambulatory appliance skin-adherent patch
Provox StabiliBase (15 pcs) 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 d0a8e698-1d64-4d20-ab26-5a56756b3802 36 fields · synced Jun 1, 2026