Comfort Soft Plus - Comfort Soft Plus Adult Cannula Soft Tubing - WESTMED, INC.

Duns Number:092673953

Device Description: Comfort Soft Plus Adult Cannula Soft Tubing Harness Soft Prongs W/14' Kink Resistant Tubi Comfort Soft Plus Adult Cannula Soft Tubing Harness Soft Prongs W/14' Kink Resistant Tubing Standard Connector (TwinMed)

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More Product Details

Catalog Number

-

Brand Name

Comfort Soft Plus

Version/Model Number

1002345

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

dd4032d3-9af9-46fa-86c2-6c18b4eb9cbd

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Additional Identifiers

Package DI Number

10709078014199

Quantity per Package

50

Contains DI Package

00709078014192

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