therMaxTherMax Blood Warmer 955516

GUDID 37332414123933

The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.

BAXTER HEALTHCARE CORPORATION

Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set
Primary Device ID37332414123933
NIH Device Record Key683ee3b2-ec4a-4b3a-8c46-cdb28e1348b6
Commercial Distribution StatusIn Commercial Distribution
Brand NametherMaxTherMax Blood Warmer
Version Model Number955516
Catalog Number955516
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414123932 [Primary]
GS137332414123933 [Package]
Contains: 07332414123932
Package: CASE [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [therMaxTherMax Blood Warmer]

37332414123933The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in com
00085412639505The TherMax blood warmer is an accessory device intended for use with the PrisMax system and app

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.