Di-Chem Hemodialysate Additive

GUDID B637BAK131

Potassium chloride additive for bicarbonate dialysis.

Di-Chem, Incorporated

Haemodialysis concentrate

• Primary Device ID: B637BAK131
• NIH Device Record Key: 3596ef45-bc54-4faa-8831-266845bbcbf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Di-Chem Hemodialysate Additive
• Version Model Number: BAK-13
• Company DUNS: 108677253
• Company Name: Di-Chem, Incorporated
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 800-847-2598
• Email: info@dichem-us.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B637BAK130 [Unit of Use]
HIBCC	B637BAK131 [Primary]

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-09-13

On-Brand Devices [Di-Chem Hemodialysate Additive]

• B637KAC2001: Liquid potassium acetate additive for bicarbonate dialysis.
• B637CA2001: Liquid calcium chloride additive for bicarbonate dialysis.
• B637BAK921: Potassium chloride additive for bicarbonate dialysis.
• B637BAK911: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9091: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9081: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9071: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9061: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9051: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9041: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9031: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9021: Potassium chloride additive for bicarbonate dialysis.
• B637BAK9011: Potassium chloride additive for bicarbonate dialysis.
• B637BAK901: Potassium chloride additive for bicarbonate dialysis.
• B637BAK131: Potassium chloride additive for bicarbonate dialysis.
• B637BAK121: Potassium chloride additive for bicarbonate dialysis.
• B637BAK111: Potassium chloride additive for bicarbonate dialysis.
• B637BAK101: Potassium chloride additive for bicarbonate dialysis.
• B637BAK081: Potassium chloride additive for bicarbonate dialysis.
• B637BAK061: Potassium chloride additive for bicarbonate dialysis.
• B637BAC9661: Calcium chloride additive for bicarbonate dialysis.
• B637BAC9651: Calcium chloride additive for bicarbonate dialysis.
• B637BAC9641: Calcium chloride additive for bicarbonate dialysis.
• B637BAC9631: Calcium chloride additive for bicarbonate dialysis.
• B637BAC9621: Calcium chloride additive for bicarbonate dialysis.
• B637BAC9611: Calcium chloride additive for bicarbonate dialysis.
• B637BAC211: Calcium chloride additive for bicarbonate dialysis.
• B637BAC201: Calcium chloride additive for bicarbonate dialysis.
• B637BAC041: Calcium chloride additive for bicarbonate dialysis.
• B637BAC031: Calcium chloride additive for bicarbonate dialysis.
• B637BAC021: Calcium chloride additive for bicarbonate dialysis.
• B637BAC011: Calcium chloride additive for bicarbonate dialysis.