Catalog Number

-

Brand Name

AUTOTRANSFUSION ACCESSORIES

Version/Model Number

BT036 - AAL

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

K020647,K020647

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

ae06744d-b7bf-4944-87ac-5d37fbdd5616

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2015

Package DI Number

38033178105584

Quantity per Package

10

Contains DI Package

08033178105583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX