Catalog Number

500-03518

Brand Name

CureWrap™

Version/Model Number

Infant, Up to 4Kg

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

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

3d78e105-15de-4a59-b19c-d2d4204d3eff

Public Version Date

September 09, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

17290012127189

Quantity per Package

8

Contains DI Package

07290012127182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box