Catalog Number

-

Brand Name

BleedArrest ER

Version/Model Number

9110264

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102459,K102459,K102459

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

a3fa4ee4-af8a-49f7-9087-12326504d172

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

February 20, 2020

Package DI Number

00858439001477

Quantity per Package

5

Contains DI Package

00858439001460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton