Identity
- Trade Name
- 120" Anesthesia Breathing Circuit FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- 120" Anesthesia Breathing Circuit, B/V Filter, GSE 10' x .060 ID M/M GSL, In-line Mini HMEF, Parallel WYE w/Temperature Port and GSP, 3L not made made with latex bag, 900 large adult mask FDA UDI
- Model / Reference
- 9187 FDA UDI
- Description
- 120" Anesthesia Breathing Circuit, B/V Filter, GSE 10' x .060 ID M/M GSL, In-line Mini HMEF, Parallel WYE w/Temperature Port and GSP, 3L not made made with latex bag, 900 large adult mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078009662 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia breathing circuit, single-use
120" Anesthesia Breathing Circuit by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, single-use.
- Vital Signs™ — Airlife, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Vital Signs™ — Airlife, Inc. · Class I
- UNIVERSAL FLEX2®BREATHING CIRCUIT & PACK KIT — KING SYSTEMS CORPORATION. · Class I
- Vital Signs™ — Airlife, Inc. · Class I
- Portex — ICU MEDICAL, INC. · Class I
- UNIVERSAL FLEX2® — KING SYSTEMS CORPORATION. · Class I
- PEDIATRIC ULTRA FLEX® — KING SYSTEMS CORPORATION. · Class I
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 343398cd-512e-455b-812d-b9ed7ed38c68 34 fields · synced May 29, 2026