Catalog Number

-

Brand Name

Care One

Version/Model Number

F405-605CO1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

8be04c61-849e-4953-8f0d-885f53ef8d9e

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

10041520974829

Quantity per Package

4

Contains DI Package

20025715036575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box