Citric Complete

GUDID 00817411021209

Dry Citric Acid Acidified Concentrate for Hemodialysis

NIPRO RENAL SOLUTIONS USA CORPORATION

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate

• Primary Device ID: 00817411021209
• NIH Device Record Key: aa39030d-59f2-402c-91e7-c6c5699247c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Citric Complete
• Version Model Number: DCA+200-25
• 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	00817411021209 [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: 2020-10-07
• Device Publish Date: 2020-09-29

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