Identity
- Trade Name
- Anesthesia Circuits FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Disposable Anesthesia Circuits, Adult 108" FDA UDI
- Model / Reference
- 8143 FDA UDI
- Description
- Disposable Anesthesia Circuits, Adult 108" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078004339 FDA UDI
- 510(k) Number
- K922492 FDA UDI
- FDA Product Code
- CAH FDA UDIOFP FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI868.5240 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: Anaesthesia breathing circuit, single-useHeat/moisture exchanger/microbial medical gas filter
Anesthesia Circuits by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K922492 also covers:
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
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
- Westmed, Inc.
Sources (1)
- FDA UDI b72c5aaf-1b81-4a65-925b-6a7bff377d7f 34 fields · synced Jun 8, 2026