Pneumoclean Electrostatic Filter(5 pcs/pkg) - ATOM MEDICAL CORPORATION

Duns Number:690632047

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More Product Details

Catalog Number

60269

Brand Name

Pneumoclean Electrostatic Filter(5 pcs/pkg)

Version/Model Number

60269

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)

-

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

FMZ

Product Code Name

Incubator, Neonatal

Device Record Status

Public Device Record Key

ce0134b7-7da5-4f38-b51b-825ae0f51811

Public Version Date

January 29, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14942962602690

Quantity per Package

5

Contains DI Package

04942962602693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ATOM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 40