AccessGUDID - DEVICE: therMaxTherMax Blood Warmer (00085412639505)

GUDID

Device Identifier (DI) Information

Brand Name: therMaxTherMax Blood Warmer
Version or Model: 955630
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 955630
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412639505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47616	Conduction blood/fluid warmer	An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, high permeability with or without sealed dialysate system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190910	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ca1bf7e1-b828-4617-b975-21cf61b61240
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: January 31, 2020