Outset Liquid Bicarbonate Concentrate

GUDID 30677964068196

MEDIVATORS INC.

Haemodialysis concentrate
Primary Device ID30677964068196
NIH Device Record Key9b79b41c-69e0-4938-b8e5-793ddaa5dc91
Commercial Distribution StatusIn Commercial Distribution
Brand NameOutset Liquid Bicarbonate Concentrate
Version Model NumberB-100
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
GS100677964068195 [Primary]
GS130677964068196 [Package]
Contains: 00677964068195
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

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