Catalog Number

ABS-4001

Brand Name

ABS Velcro Pad

Version/Model Number

Model 4001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 24, 2020

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

ORC

Product Code Name

Air Filter Portable Apparatus

Public Device Record Key

339a9c54-efd0-4ba8-a199-733d7de09ce7

Public Version Date

February 24, 2022

Public Version Number

4

DI Record Publish Date

October 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-