Catalog Number

BQF02-US

Brand Name

HEMOBLAST Bellows

Version/Model Number

BQF02

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

Yes

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

-

FDA Premarket Submission

P170012,P170012

Product Code

PMX

Product Code Name

Absorbable Collagen Hemostatic Agent With Thrombin

Public Device Record Key

ad8aa1bb-2cda-4c70-9f51-60d38b652c28

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

March 19, 2018

Package DI Number

13760193182702

Quantity per Package

12

Contains DI Package

03760193182705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton