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Uni-lim Coaxial Circuit

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
Uni-lim Coaxial Circuit FDA UDI
Generic Name
Anaesthesia breathing circuit, single-use FDA UDI
Device Name
Anesthesia Circuit, Adult, Uni-lim, 60" Coaxial, w/24" flex expiatory lead, Inner Elbow w/GSP, In-Line Mini HMEF, Large adult mask with 10' suction tubing, 3L not made with latex bag, 10' x .050" ID M/M GSL, non vented non sterile yankauer FDA UDI
Model / Reference
9615 FDA UDI
Description
Anesthesia Circuit, Adult, Uni-lim, 60" Coaxial, w/24" flex expiatory lead, Inner Elbow w/GSP, In-Line Mini HMEF, Large adult mask with 10' suction tubing, 3L not made with latex bag, 10' x .050" ID M/M GSL, non vented non sterile yankauer FDA UDI

Identifiers

Primary DI / UDI-DI
00709078008030 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Uni-lim Coaxial 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 2edbfcd2-aeb2-45eb-af95-80fdddfe8fca 35 fields · synced May 31, 2026