Identity
- Trade Name
- Vibralung Patient Kit FDA UDI
- Generic Name
- Electroacoustical airway secretion-clearing system FDA UDI
- Device Name
- 1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on Cone pre-attached, and disposable ear plugs. FDA UDI
- Model / Reference
- 9600 FDA UDI
- Description
- 1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on Cone pre-attached, and disposable ear plugs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078001369 FDA UDI
- 510(k) Number
- K133057 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Electroacoustical airway secretion-clearing system 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: Electroacoustical airway secretion-clearing system
Vibralung Patient Kit by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroacoustical airway secretion-clearing system.
- Vibralung Full User Kit/Travel Bag — WESTMED, INC. · Class II
- Vibralung Mask Interface Kit-Adult with Aerosol Delivery System — WESTMED, INC. · Class II
- VIBRALUNG® — WESTMED, INC. · Class II
- Vibralung Mask Interface Kit-Pediatric w/Aerosol Delivery System — WESTMED, INC. · Class II
- Vibralung Patient Change Kit — WESTMED, INC. · Class II
- Vibralung Treatment Control Unit — WESTMED, INC. · Class II
- Vibralung Battery Charger — WESTMED, INC. · Class II
- VIBRALUNG® — 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 |
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Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI 61c20187-a756-4992-8b4c-e23414e4efce 35 fields · synced Jun 6, 2026