PSDS Bicarb Systems

GUDID 00817492021112

MAR COR PURIFICATION, INC.

Haemodialysis system bicarbonate mixer
Primary Device ID00817492021112
NIH Device Record Key6412dddd-ed22-419a-82f5-94cef903b855
Commercial Distribution StatusIn Commercial Distribution
Brand NamePSDS Bicarb Systems
Version Model NumberPSDS,3 ACID,1 BICARB
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

Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 Inch
Height58 Inch
Depth48 Inch
Width110 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
GS100817492021112 [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 [PSDS Bicarb Systems]

00817492021129PSDS,3 ACID,1 BICARB,HD
00817492021112PSDS,3 ACID,1 BICARB
00817492021105PSDS,2 ACID,1 BICARB,HD
00817492021099PSDS,2 ACID,1 BICARB
00817492021082PSDS,1 ACID,1 BICARB,HD
00817492021075PSDS,1 ACID,1 BICARB
00817492021068PSDS,BICARB ONLY,HD
00817492021051PSDS,BICARB ONLY

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