Disposable Anesthesia Circuit - Adult Large Anesthesia Mask - WESTMED, INC.

Duns Number:092673953

Device Description: Adult Large Anesthesia Mask

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More Product Details

Catalog Number

-

Brand Name

Disposable Anesthesia Circuit

Version/Model Number

7-9529

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

621674bd-23b4-4310-9c8c-997f2f9de88c

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

10709078013895

Quantity per Package

30

Contains DI Package

00709078013898

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