Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA2230-PM

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

K101705,K101705

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

81fc85dd-68f0-4ad1-8a77-219e729ba83e

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2022

Package DI Number

18719867000618

Quantity per Package

40

Contains DI Package

18719867000601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX