Citric Complete

GUDID 00817411021186

Dry Citric Acid

DIMESOL USA, LLC

Haemodialysis concentrate

• Primary Device ID: 00817411021186
• NIH Device Record Key: c082afe8-91ea-4020-9549-87f08496be5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Citric Complete
• Version Model Number: DCA-228
• Company DUNS: 069723499
• Company Name: DIMESOL USA, LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817411021186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171750

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: 2018-11-23
• Device Publish Date: 2018-10-23

On-Brand Devices [Citric Complete]

• 00817411021186: Dry Citric Acid
• 00817411021179: Dry Citric Acid
• 00817411021162: Dry Citric Acid
• 00817411021155: Dry Citric Acid
• 00817411021148: Dry Citric Acid
• 00817411021131: Dry Citric Acid
• 00817411021124: Dry Citric Acid
• 00817411021117: Dry Citric Acid
• 00817411021100: Dry Citric Acid