Identity
- Trade Name
- Avea FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- GAS & HOSE KIT TABLE VMAX 22 FDA UDI
- Model / Reference
- 769734 FDA UDI
- Description
- GAS & HOSE KIT TABLE VMAX 22 FDA UDI
Identifiers
- Catalog Number
- 769734 FDA UDI
- Primary DI / UDI-DI
- 10190752163300 FDA UDI
- 510(k) Number
- K942211 FDA UDI
- FDA Product Code
- BTY FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neonatal/adult intensive-care ventilator
Avea by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal/adult intensive-care ventilator.
- Aeroneb Module control cable — Maquet Critical Care AB · Class II
- Puritan Bennett — Covidien LP · Class II
- Neumovent — Tecme Corporation · Class II
- Puritan Bennett — Covidien LP · Class II
- Puritan Bennett — Covidien LP · Class II
- Newport — Newport Medical Instruments · Class II
- Puritan Bennett — Covidien LP · Class II
- V8800 Critical Care Ventilator — ORICARE INC. · Class II
Cleared under the same submission
K942211 also covers:
- AVEA — VYAIRE MEDICAL, INC.
- Avea — VYAIRE MEDICAL, INC.
- FreeFlow™ — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI 73b33839-27fa-4911-be1a-7b06d57a16c7 36 fields · synced May 30, 2026