Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA1640-PM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

7ac93384-7d8e-4a47-83cc-b71563c5c67b

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

August 30, 2016

Package DI Number

ET37MA1640PM1

Quantity per Package

10

Contains DI Package

ET37MA1640PM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box