CLEARLINK/BURETROL 2R8864

GUDID 50085412565700

Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar

BAXTER HEALTHCARE CORPORATION

Burette intravenous administration set
Primary Device ID50085412565700
NIH Device Record Keyc32b2751-444b-4fe8-a326-957846f6bb97
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARLINK/BURETROL
Version Model Number2R8864
Catalog Number2R8864
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 Datefalse
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
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
GS100085412565705 [Primary]
GS150085412565700 [Package]
Contains: 00085412565705
Package: CASE [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, administration, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

05413765852428 - Novum IQ2024-09-23 The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient
20085412676610 - DOSE IQ SAFETY SOFTWARE2024-09-02 Infusion Safety Management Software
20085412841629 - MINICAP EXTENDED LIFE PD TRNS2024-08-13 This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This
50197886004354 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1
50197886004361 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9
10085412676613 - DOSE IQ SAFETY SOFTWARE2024-04-30 Infusion Safety Management Software
05413765851797 - Novum IQ2024-04-18 The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a
51978860004350 - CLEARLINK/CONTINU-FLO2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1

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