Catalog Number

PED-X2001

Brand Name

CureWrap™

Version/Model Number

X-Large Pediatric over 135cm (single)

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

d4944f27-e0fa-44fa-b01e-c42aea9fa316

Public Version Date

September 09, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

77290107580266

Quantity per Package

4

Contains DI Package

07290107580267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box