Catalog Number

AA0608-01 and AA0608

Brand Name

AngiAssist®

Version/Model Number

AA0608-01 and AA0608

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2022

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"

Yes

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

-

Product Code

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

4b871b84-b2d2-4227-810c-7050366f515c

Public Version Date

August 15, 2022

Public Version Number

3

DI Record Publish Date

July 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-