Catalog Number

-

Brand Name

HypothermX HX100 Intravenous Fluid and Blood Warmer

Version/Model Number

FA100001

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

K103801,K103801,K103801,K103801,K103801,K103801

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

fff3fa36-7042-4522-8656-128908421599

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2018

Package DI Number

00850003277035

Quantity per Package

2

Contains DI Package

00850003277004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

2 Pack