MedicaPure

GUDID 10817411021435

Liquid Acidified Concentrate for Hemodialysis

NIPRO RENAL SOLUTIONS USA CORPORATION

Haemodialysis concentrate

• Primary Device ID: 10817411021435
• NIH Device Record Key: b2b3f91e-eee0-439f-b048-d37d75db9e65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaPure
• Version Model Number: AC+202
• 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: 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	00817411020080 [Previous]
GS1	00817411021438 [Primary]
GS1	10817411021435 [Package]; Contains: 00817411021438; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901471

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 [MedicaPure]

• 00817411021476: Liquid Acidified Concentrate for Hemodialysis (55-gallon drum)
• 10817411021466: Liquid Acidified Concentrate for Hemodialysis
• 00817411021445: Liquid Acidified Concentrate for Hemodialysis (55-gallon drum)
• 10817411021435: Liquid Acidified Concentrate for Hemodialysis
• 00817411021414: Liquid Acidified Concentrate for Hemodialysis (55-gallon drum)
• 10817411021404: Liquid Acidified Concentrate for Hemodialysis
• 00817411021384: Liquid Acidified Concentrate for Hemodialysis (55-gallon drums)
• 10817411021374: Liquid Acidified Concentrate for Hemodialysis
• 10817411022524: Liquid Acid Concentrate
• 10817411022487: Liquid Acid Concentrate
• 10817411022449: Liquid Acid Concentrate
• 10817411022425: Liquid Acid Concentrate
• 10817411022050: Liquid Acid Concentrate
• 10817411022036: Liquid Acid Concentrate
• 10817411021992: Liquid Acid Concentrate
• 10817411021978: Liquid Acid Concentrate
• 10817411021893: Liquid Acid Concentrate
• 10817411021879: Liquid Acid Concentrate
• 10817411021855: Liquid Acid Concentrate
• 10817411021732: Liquid Acid Concentrate
• 10817411022012: Liquid Acid Concentrate
• 10817411021954: Liquid Acid Concentrate
• 10817411021534: Liquid Acid Concentrate