Citric Complete

GUDID 00817411021315

Dry Citric Acid Concentrate

NIPRO RENAL SOLUTIONS USA CORPORATION

Haemodialysis concentrate

• Primary Device ID: 00817411021315
• NIH Device Record Key: 68cdabec-fde3-4283-9be0-65adfd94948c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Citric Complete
• Version Model Number: DCA+226-16.5
• Company DUNS: 117439434
• Company Name: NIPRO RENAL SOLUTIONS USA CORPORATION
• 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: true
• 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	00817411021315 [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: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Citric Complete]

• 00817411021261: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021254: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021247: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021230: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021223: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021216: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021209: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021193: Dry Citric Acid Acidified Concentrate for Hemodialysis
• 00817411021360: Dry Citric Acid Concentrate
• 00817411021353: Dry Citric Acid Concentrate
• 00817411021346: Dry Citric Acid Concentrate
• 00817411021339: Dry Citric Acid Concentrate
• 00817411021322: Dry Citric Acid Concentrate
• 00817411021315: Dry Citric Acid Concentrate
• 00817411021308: Dry Citric Acid Concentrate
• 00817411021292: Dry Citric Acid Concentrate
• 00817411021285: Dry Citric Acid Concentrate
• 00817411021278: Dry Citric Acid Concentrate
• 00817411023180: Liquid Citric Acid Concentrate Drum
• 00817411023173: Liquid Citric Acid Concentrate
• 10817411023163: Liquid Citric Acid Concentrate
• 10817411023156: Liquid Citric Acid Concentrate
• 10817411023149: Liquid Citric Acid Concentrate
• 10817411023132: Liquid Citric Acid Concentrate
• 10817411023125: Liquid Citric Acid Concentrate
• 10817411023118: Liquid Citric Acid Concentrate
• 10817411023101: Liquid Citric Acid Concentrate
• 10817411023095: Liquid Citric Acid Concentrate
• 10817411023088: Liquid Citric Acid Concentrate
• 10817411020032: Liquid Citric Acid Concentrate
• 10817411020025: Liquid Citric Acid Concentrate
• 10817411020018: Liquid Citric Acid Concentrate
• 00817411023197: Liquid Citric Acid Concentrate Drum