Catalog Number

1905-0001

Brand Name

Soft Air

Version/Model Number

A635

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

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

c48fcc5a-2f57-4051-86cc-7455143f062a

Public Version Date

August 06, 2019

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

20615089196304

Quantity per Package

5

Contains DI Package

10615089196307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton