Hemo-Dial C94BX

GUDID 00857940006681

CALCIUM CHLORIDE USP 9.4 GRAMS - HEMODIALYSATE ADDITIVE - 0.75 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM

EDLAW PHARMACEUTICALS, INC.

Haemodialysis concentrate

• Primary Device ID: 00857940006681
• NIH Device Record Key: 5072a96e-0bdf-411b-84a0-8fc743540c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemo-Dial
• Version Model Number: C94BX
• Catalog Number: C94BX
• Company DUNS: 029646569
• Company Name: EDLAW PHARMACEUTICALS, INC.
• Device Count: 125
• 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: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net
• Phone: 631-454-6888
• Email: edlawpharm@optonline.net

Device Dimensions

• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound
• Weight: 3.9 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857940006681 [Unit of Use]
GS1	10857940006688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K813388

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: 2022-03-04
• Device Publish Date: 2022-02-24

On-Brand Devices [Hemo-Dial]

• 10857940006596: CALCIUM CHLORIDE 3.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3
• 00857940006681: CALCIUM CHLORIDE USP 9.4 GRAMS - HEMODIALYSATE ADDITIVE - 0.75 mEq/L INCREASE WHEN ADDED TO 3.78
• 00857940006674: CALCIUM CHLORIDE USP 3.1 GRAMS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.78