PSDS Bicarb Systems

GUDID 00817492021075

MAR COR PURIFICATION, INC.

Haemodialysis system bicarbonate mixer

• Primary Device ID: 00817492021075
• NIH Device Record Key: e6a1934e-469b-44b1-b86b-7722990574bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSDS Bicarb Systems
• Version Model Number: PSDS,1 ACID,1 BICARB
• Company DUNS: 019056181
• Company Name: MAR COR PURIFICATION, INC.
• Device Count: 1
• DM Exempt: true
• 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: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 Inch
• Height: 58 Inch
• Depth: 48 Inch
• Width: 110 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	00817492021075 [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 [PSDS Bicarb Systems]

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