Catalog Number

-

Brand Name

COMFORTMATE FLUID WARMER DISPOSABLE

Version/Model Number

FWS-209-B

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"

Yes

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

-

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

fce749ee-bb39-4b3e-a083-34d954a14d3d

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

M535FWS209B5

Quantity per Package

24

Contains DI Package

M535FWS209B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-