Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA5250-PM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171234,K171234

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

4c03c4c9-6ff8-4725-a8d7-7fc7a61a0b74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 07, 2017

Package DI Number

ET375250PM0

Quantity per Package

1

Contains DI Package

ET37MA5250PM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box