Aero-Pro HEPA Small Straight - PULMODYNE INC

Duns Number:030619483

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More Product Details

Catalog Number

-

Brand Name

Aero-Pro HEPA Small Straight

Version/Model Number

20162

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

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 Details

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

0a058042-63ed-4606-867c-143e4c7b5de5

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Additional Identifiers

Package DI Number

10841470109896

Quantity per Package

25

Contains DI Package

00841470109899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PULMODYNE INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 491