Catalog Number

-

Brand Name

BRAT 2

Version/Model Number

OUTLET CLAMP

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

K974897,K974897,K974897

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

b2bce0f6-3656-464e-b4f4-1206bb563bc7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 06, 2015

Package DI Number

38033178106154

Quantity per Package

144

Contains DI Package

18033178106150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX