Oxygen Tubing, 7' KROT, w/ (2) Long Straights - Oxygen Tubing, 7' KROT, w/ (2) Long Straights - WESTMED, INC.

Duns Number:092673953

Device Description: Oxygen Tubing, 7' KROT, w/ (2) Long Straights

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More Product Details

Catalog Number

-

Brand Name

Oxygen Tubing, 7' KROT, w/ (2) Long Straights

Version/Model Number

0007

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

9fa9d0cf-972c-4c9c-8b27-e0d149c97fca

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

April 11, 2017

Additional Identifiers

Package DI Number

10709078003384

Quantity per Package

50

Contains DI Package

00709078003387

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