AG Industries - Compressor Filter (Non-Platinum Units) - AG INDUSTRIES LLC

Duns Number:080410233

Device Description: Compressor Filter (Non-Platinum Units)

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More Product Details

Catalog Number

BF90

Brand Name

AG Industries

Version/Model Number

BF900

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

87622ebe-a581-4c58-859f-d68967fa468c

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

April 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AG INDUSTRIES LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28