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Disposable Anesthesia Breathing Circuit

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
Disposable Anesthesia Breathing Circuit FDA UDI
Generic Name
Anaesthesia breathing circuit, single-use FDA UDI
Device Name
Anesthesia Circuit, Pediatric, 96" Expandable, GSE w/Cap, Parallel Wye, GSL 10' x .060" ID M/M 2L Not Made With Latex Breathing Bag, B/V Filter, In-Line Mini HME FDA UDI
Model / Reference
8625 FDA UDI
Description
Anesthesia Circuit, Pediatric, 96" Expandable, GSE w/Cap, Parallel Wye, GSL 10' x .060" ID M/M 2L Not Made With Latex Breathing Bag, B/V Filter, In-Line Mini HME FDA UDI

Identifiers

Primary DI / UDI-DI
00709078009525 FDA UDI
510(k) Number
K922492 FDA UDI
FDA Product Code
OFP FDA UDI
CAH FDA UDI
GMDN Term
Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5240 FDA UDI
868.5260 FDA UDI
Commercial Distribution
Not 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

Disposable Anesthesia Breathing Circuit by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K922492 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI ad6b4113-ad76-4bda-9b61-76c25008a779 35 fields · synced May 30, 2026