Disposable Circuit - Circuit, Disposable, 22mm, Non-Heated Dual Limb - WESTMED, INC.

Duns Number:092673953

Device Description: Circuit, Disposable, 22mm, Non-Heated Dual Limb w/ BV filter

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More Product Details

Catalog Number

-

Brand Name

Disposable Circuit

Version/Model Number

8205

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

134e7d19-d273-4df8-be16-aabbb33648f7

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2020

Additional Identifiers

Package DI Number

10709078008679

Quantity per Package

10

Contains DI Package

00709078008672

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