Identity
- Trade Name
- Provox XtraFlange 20 FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only. FDA UDI
- Model / Reference
- 7276 FDA UDI
- Description
- Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only. FDA UDI
Identifiers
- Catalog Number
- 7276 FDA UDI
- Primary DI / UDI-DI
- 07331791006937 FDA UDI
- 510(k) Number
- K092593 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, indwelling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheoesophageal speech valve, indwelling
Provox XtraFlange 20 by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheoesophageal speech valve, indwelling.
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- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class I
Cleared under the same submission
K092593 also covers:
- Provox ActiValve Light 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 4.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 8 mm — ATOS MEDICAL INC.
- Provox ActiValve Lubricant — ATOS MEDICAL INC.
- Provox ActiValve Strong 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 4.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 8 mm — ATOS MEDICAL INC.
- Provox ActiValve XtraStrong 10 mm — ATOS MEDICAL INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 806722a5-32a7-4508-8a45-32e180e0464a 38 fields · synced Jun 8, 2026