Dri-Sate DF-109

GUDID 00814963021312

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate

• Primary Device ID: 00814963021312
• NIH Device Record Key: b7776e76-f4dd-4f19-9b01-a9d9e484699d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dri-Sate
• Version Model Number: DF-109
• Catalog Number: DF-109
• Company DUNS: 933721433
• Company Name: ROCKWELL MEDICAL, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814963021312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981003

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-12

On-Brand Devices [Dri-Sate]

• 00814963021329: DC-216
• 00814963021312: DF-109
• 00814963021190: DC-112