Catalog Number

B270

Brand Name

Hot Dog Pediatric Head Warming Wrap, Small

Version/Model Number

B270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K112488

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

6f3f960f-c7c8-4d2c-bbbe-804cebec3665

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-