Identity
- Trade Name
- Vivo 50, Vivo 65, Vivo 45 LS FDA UDI
- Generic Name
- Ventilator converter FDA UDI
- Device Name
- Oxygen adapter low pressure FDA UDI
- Model / Reference
- 005032 FDA UDI
- Description
- Oxygen adapter low pressure FDA UDI
Identifiers
- Catalog Number
- 005032 FDA UDI
- Primary DI / UDI-DI
- 07321820050321 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- GMDN Term
- Ventilator converter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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: Ventilator converter
Vivo 50, Vivo 65, Vivo 45 LS by Breas Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator converter.
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Vivo 45 LS — Breas Medical AB · Class II
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
- Breas Medical, Inc.
Sources (1)
- FDA UDI db451dd0-137e-4e39-9f7f-15f00e31c368 35 fields · synced Jun 8, 2026