Catalog Number

PED-M2001

Brand Name

CureWrap™

Version/Model Number

Medium2 Pediatric 79-91 cm (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

5914733d-99cf-4d17-a73f-340bdd72cb6d

Public Version Date

September 09, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

77290107580167

Quantity per Package

4

Contains DI Package

07290107580168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box