Identity
- Trade Name
- Transport Set FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- Norman elbow, 3l latex free breathing bag w/cut tail, 7' KROT w/long straight and threaded nut connectors FDA UDI
- Model / Reference
- 6214 FDA UDI
- Description
- Norman elbow, 3l latex free breathing bag w/cut tail, 7' KROT w/long straight and threaded nut connectors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078001710 FDA UDI
- FDA Product Code
- BZR FDA UDI
- GMDN Term
- Breathing circuit bag, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Breathing circuit bag, single-use
Transport Set by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Breathing bag anest disp 1L compl — Maquet Critical Care 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 II | Pending data |
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Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI b4ee987e-c276-4381-afd5-02d2e31b1cba 33 fields · synced Jun 1, 2026