Catalog Number

8003-003-002

Brand Name

Altrix Temperature Management Wraps

Version/Model Number

8003-003-002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K171149,K171149

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

8f4c7ca4-68ec-44ee-9b71-bc3db18eabfe

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Package DI Number

57613327374266

Quantity per Package

5

Contains DI Package

07613327374261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case