Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA3400-PM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

e00d535c-1225-4530-8407-6a77e9694c36

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2022

Package DI Number

18719867001370

Quantity per Package

40

Contains DI Package

18719867001363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX