Catalog Number

-

Brand Name

AUTOTRANSFUSION ACCESSORIES

Version/Model Number

COD. 151 E

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

K963758,K963758,K963758

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

867aceec-2f94-417a-b9e7-53aa00f9c0f5

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

18033178105610

Quantity per Package

4

Contains DI Package

08033178105613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX