Cosmed Bod Pod Tube and Filter Kit - US & Canada - Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod - - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod - US and Canada

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More Product Details

Catalog Number

180014

Brand Name

Cosmed Bod Pod Tube and Filter Kit - US & Canada

Version/Model Number

Bod Pod Tube and Filter Kit - US & Canada - 180014

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

K063526,K063526

Product Code Details

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

3fbf1a31-eced-4d0b-aa1a-d71d222ab694

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Additional Identifiers

Package DI Number

00817081022582

Quantity per Package

50

Contains DI Package

00817081022575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"A-M SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 126