Hot Dog Chest and Torso Warming Blanket - Labeled: Hot Dog Chest and Torso Warming Blanket - AUGUSTINE TEMPERATURE MANAGEMENT LLC

Duns Number:965879187

Device Description: Labeled: Hot Dog Chest and Torso Warming Blanket B110

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More Product Details

Catalog Number

B110

Brand Name

Hot Dog Chest and Torso Warming Blanket

Version/Model Number

B110

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

K052392

Product Code Details

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Device Record Status

Public Device Record Key

5dd1e7a2-0b79-4e72-969d-86ef3631309a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AUGUSTINE TEMPERATURE MANAGEMENT LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 35