Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA1100-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"

-

For Single-Use

-

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

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

77cac53a-6f19-4833-b172-e1af2c555e03

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-