Identity
- Trade Name
- Vivo 1/2, Vivo 3 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Circuit: Single limb 22 mm. Single patient multiple use (30-pack) FDA UDI
- Model / Reference
- 004465 FDA UDI
- Description
- Circuit: Single limb 22 mm. Single patient multiple use (30-pack) FDA UDI
Identifiers
- Catalog Number
- 008426 FDA UDI
- Primary DI / UDI-DI
- 07321820084265 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator breathing circuit, reusable
Vivo 1/2, Vivo 3 by Breas Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, reusable.
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- RESMED — RESMED PTY LTD · Class I
- Vivo Series — Breas Medical AB · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical, Inc.
Sources (1)
- FDA UDI fc7fd31c-ef87-4f0d-aaa9-c131fc14a3c5 34 fields · synced Jun 8, 2026