Catalog Number

225-028-852

Brand Name

Ambulating Bulb

Version/Model Number

225-028-852

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

5c6b6603-3c53-4f57-97f4-96dbc4fe2886

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 2021

Package DI Number

00855168008586

Quantity per Package

10

Contains DI Package

00855168008579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack