Catalog Number

83442

Brand Name

FilteredFlo® Lower Body OR Blanket

Version/Model Number

442

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"

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

ff5db064-2a0c-4978-927b-1a664709121c

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

August 26, 2016

Package DI Number

30613031834424

Quantity per Package

40

Contains DI Package

20613031834427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case