Catalog Number

82870

Brand Name

Maxi-Therm®Lite

Version/Model Number

870

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"

Yes

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

aeb0419b-d74e-425d-baf3-c69ef9ce3e6c

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

August 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-