Catalog Number

82276

Brand Name

Maxi-Therm®

Version/Model Number

276

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

21e61b20-3ab4-41ad-9dd6-f7c22dc0a4a2

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

August 30, 2017

Package DI Number

30613031822766

Quantity per Package

4

Contains DI Package

20613031822769

Package Discontinue Date

-

Package Status

-

Package Type

-