Identity
- Trade Name
- Vibralung Patient Kit FDA UDI
- Generic Name
- Pneumatic chest percussor FDA UDI
- Model / Reference
- 9600-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078001352 FDA UDI
- 510(k) Number
- K133057 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Pneumatic chest percussor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumatic chest percussor
Vibralung Patient Kit by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic chest percussor.
- FluidFlo — Med Systems · Class I
- Vibralung Patient Kit with Circulair II Model 0295 — WESTMED, INC. · Class II
Cleared under the same submission
K133057 also covers:
- VIBRALUNG® — WESTMED, INC.
- VIBRALUNG® — WESTMED, INC.
- VIBRALUNG® — WESTMED, INC.
- Vibralung Battery Charger — WESTMED, INC.
- Vibralung Full User Kit/Travel Bag — WESTMED, INC.
- Vibralung Mask Interface Kit-Adult with Aerosol Delivery System — WESTMED, INC.
- Vibralung Mask Interface Kit-Pediatric w/Aerosol Delivery System — WESTMED, INC.
- Vibralung Patient Change Kit — WESTMED, INC.
- Vibralung Patient Kit — WESTMED, INC.
- Vibralung Patient Kit with Circulair II Model 0295 — WESTMED, INC.
- Vibralung Trach Interface Kit with Aerosol Delivery System — WESTMED, INC.
- Vibralung Treatment Control Unit — WESTMED, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI fee07846-739a-42a1-b0d9-a622d2800fd5 34 fields · synced Jun 8, 2026