Adult Nasal Cannula for GI Source - Adult Nasal Cannula, Soft Tipped, with 14' KROT - WESTMED, INC.

Duns Number:092673953

Device Description: Adult Nasal Cannula, Soft Tipped, with 14' KROT

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More Product Details

Catalog Number

-

Brand Name

Adult Nasal Cannula for GI Source

Version/Model Number

08-0008

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

a9f84c75-5b19-4411-abe4-ea1b78b120c8

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

February 01, 2016

Additional Identifiers

Package DI Number

10709078622455

Quantity per Package

50

Contains DI Package

00709078622458

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