Catalog Number

ABS-2002

Brand Name

ABS Blower Unit

Version/Model Number

Model 2002

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"

-

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

ORC

Product Code Name

Air Filter Portable Apparatus

Public Device Record Key

dad9b67b-6ec1-41d4-bcaa-0323cc57ac30

Public Version Date

February 24, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-