Disposable Anesthesia Circuit - Adul;t Circuit, 96" Expandable Circuit - WESTMED, INC.

Duns Number:092673953

Device Description: Adul;t Circuit, 96" Expandable Circuit

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More Product Details

Catalog Number

-

Brand Name

Disposable Anesthesia Circuit

Version/Model Number

9376

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

-

Product Code Details

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

6394f15f-ff06-4f04-b41b-d72667d3e7e6

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 31, 2019

Additional Identifiers

Package DI Number

10709078008174

Quantity per Package

20

Contains DI Package

00709078008177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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