Catalog Number

0225018000

Brand Name

NA

Version/Model Number

0225018000

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

K970714,K970714

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

3bfdcd48-0f01-4d11-a7aa-512100967d0b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2015

Package DI Number

34546540502453

Quantity per Package

10

Contains DI Package

04546540502452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack