SDS Bicarb Systems

GUDID 00817492021167

MAR COR PURIFICATION, INC.

Haemodialysis system bicarbonate mixer

Primary Device ID	00817492021167
NIH Device Record Key	95a12168-5bba-4e8a-960e-f46497f369e5
Commercial Distribution Status	In Commercial Distribution
Brand Name	SDS Bicarb Systems
Version Model Number	SDS,REMOTE,3 ACID,1 BICARB,HD,70G TANK
Company DUNS	019056181
Company Name	MAR COR PURIFICATION, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com
Phone	8006333080
Email	info@mcpur.com

Device Dimensions

Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch
Height	58 Inch
Depth	55 Inch
Width	92 Inch

Operating and Storage Conditions

Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment Temperature	Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817492021167 [Primary]

FDA Product Code

FIN	Tank, Holding, Dialysis

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-09-03
Device Publish Date	2016-09-23

On-Brand Devices [SDS Bicarb Systems]

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