Catalog Number

AA0608

Brand Name

AngiAssist®

Version/Model Number

AA0608

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

-

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

-

Product Code

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

1a6502c8-18e3-4823-b6da-a7ab07831960

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

00850033705096

Quantity per Package

10

Contains DI Package

00850033705089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case