Catalog Number

82800

Brand Name

Maxi-Therm®Lite Patient Vest

Version/Model Number

800

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

6bbef096-160f-42ea-bd42-9b4078002c5a

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2017

Package DI Number

30613031828003

Quantity per Package

4

Contains DI Package

20613031828006

Package Discontinue Date

-

Package Status

-

Package Type

-