Centrisol Liquid Bicarbonate Concentrate

GUDID 30677964000400

MEDIVATORS INC.

Haemodialysis concentrate
Primary Device ID30677964000400
NIH Device Record Keyc256f4a0-ec05-46c6-b2b9-4bf77e83b132
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentrisol Liquid Bicarbonate Concentrate
Version Model NumberMB-330-L
Company DUNS068199363
Company NameMEDIVATORS INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964000409 [Primary]
GS130677964000400 [Package]
Contains: 00677964000409
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKQSystem, Dialysate Delivery, Central Multiple Patient

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

Devices Manufactured by MEDIVATORS INC.

50677964150475 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus 5-piece Valve Kit, Drawstring Pad, Lubricant, Gauze
50677964150482 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Intercept Packet, Basin, Sponge, Defendo Olympus 5-piece Valve Kit, Cleanascope Liners, Ab
50677964150499 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Basin, Intercept Packets, Sponge, Endo Carry-On Transport Pad, Lubricant, Gauze, and Dirty
50677964150505 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus 5-pc Kit, Drawstring Pad, Lubricant, Gauze, Double
50677964150512 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus 5-pc Kit, Cleanascope Advantage Liners, Absorbent Pa
50677964150529 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Sponge, Defendo Fuji 700 5-pc Kit, Drawstring Pad, Lubricant, Gauze
50677964150536 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent Packet, Sponge, Defendo Fuji 700 5-pc Kit, Cleanascope Advantage
50067796415055 - Endo Carry-on Procedure Kit2025-06-18 Endo Carry-on Procedure Kit Includes Basin, VIA Enzymatic Sponge, Defendo Olympus 5-pc Kit, Absorbent Pads, Lubricant, Gauze, a

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.