Catalog Number

-

Brand Name

Comfort Soft Plus

Version/Model Number

0197-RC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

ce18b425-ce4d-43a8-bb46-0a494b4a02af

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 31, 2019

Package DI Number

10709078008204

Quantity per Package

50

Contains DI Package

00709078008207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-