Plastipad® Adult Size - Water Circulating Hot or Cold Pack - Gentherm Medical, LLC

Duns Number:004249462

Device Description: Water Circulating Hot or Cold Pack

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More Product Details

Catalog Number

82184

Brand Name

Plastipad® Adult Size

Version/Model Number

196CPC

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"

Yes

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Device Record Status

Public Device Record Key

172bbefd-8119-4cac-b0a8-981ca4275648

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENTHERM MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26