Uni-Lim Coaxial Circuit - Uni-Lim™, 84", Adult Coaxial Circle Anesthesia - WESTMED, INC.

Duns Number:092673953

Device Description: Uni-Lim™, 84", Adult Coaxial Circle Anesthesia Breathing Circuit w/24" Flex Expiratory Lea Uni-Lim™, 84", Adult Coaxial Circle Anesthesia Breathing Circuit w/24" Flex Expiratory Lead, GSE, (2) BV Filters, 3Lf Bag, 10' x .050 ID, GSL w/swivel elbow, Large Adult Mask

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More Product Details

Catalog Number

-

Brand Name

Uni-Lim Coaxial Circuit

Version/Model Number

9697

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K922492,K922492

Product Code Details

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

51f53776-5ba7-4b54-b568-7d8b8950cbff

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

December 24, 2021

Additional Identifiers

Package DI Number

10709078013796

Quantity per Package

20

Contains DI Package

00709078013799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320