Anesthesia Mask - Anesthesia Mask Infant 900 Series - WESTMED, INC.

Duns Number:092673953

Device Description: Anesthesia Mask Infant 900 Series

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More Product Details

Catalog Number

-

Brand Name

Anesthesia Mask

Version/Model Number

7-9904

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

4ca5e47c-7575-4515-b656-8527c0361d14

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Additional Identifiers

Package DI Number

10709078008129

Quantity per Package

20

Contains DI Package

00709078008122

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