Catalog Number

-

Brand Name

CareOne

Version/Model Number

B FMDLS 0130 R03606 AHL

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"

-

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

FRL

Product Code Name

Fiber, Medical, Absorbent

Public Device Record Key

cf788e0a-2227-4a59-84b8-4ddb545c6272

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 2020

Package DI Number

10041520078466

Quantity per Package

36

Contains DI Package

00041520863904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case