SDS Bicarb Systems

GUDID 00817492021150

MAR COR PURIFICATION, INC.

Haemodialysis system bicarbonate mixer
Primary Device ID00817492021150
NIH Device Record Key61ef8930-a0de-4dd8-9b26-db63766ed622
Commercial Distribution StatusIn Commercial Distribution
Brand NameSDS Bicarb Systems
Version Model NumberSDS,REMOTE,2 ACID,1 BICARB,HD,70G TANK
Company DUNS019056181
Company NameMAR COR PURIFICATION, 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com
Phone8006333080
Emailinfo@mcpur.com

Device Dimensions

Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch
Height58 Inch
Depth55 Inch
Width92 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817492021150 [Primary]

FDA Product Code

FINTank, Holding, Dialysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-03
Device Publish Date2016-09-23

On-Brand Devices [SDS Bicarb Systems]

00817492021280SDS,REMOTE,3 ACID,1 BICARB,100G TANK
00817492021273SDS,REMOTE,2 ACID,1 BICARB,100G TANK
00817492021266SDS,REMOTE,1 ACID,1 BICARB,100G TANK
00817492021259SDS,REMOTE,BICARB ONLY,100G TANK
00817492021242SDS,REMOTE,3 ACID,1 BICARB,70G TANK
00817492021235SDS,REMOTE,2 ACID,1 BICARB,70G TANK
00817492021228SDS,REMOTE,1 ACID,1 BICARB,70G TANK
00817492021211SDS,REMOTE,BICARB ONLY,70G TANK
00817492021204SDS,REMOTE,3 ACID,1 BICARB,HD,100G TANK
00817492021198SDS,REMOTE,2 ACID,1 BICARB,HD,100G TANK
00817492021181SDS,REMOTE,1 ACID,1 BICARB,HD,100G TANK
00817492021174SDS,REMOTE,BICARB ONLY,HD,100G,TANK
00817492021167SDS,REMOTE,3 ACID,1 BICARB,HD,70G TANK
00817492021150SDS,REMOTE,2 ACID,1 BICARB,HD,70G TANK
00817492021143SDS,REMOTE,1 ACID,1 BICARB,HD,70G TANK
00817492021136SDS,REMOTE,BICARB ONLY,HD,70G TANK

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