MedicaLyte

GUDID 10817411022401

Dry Bicarbonate Powder Concentrate for Hemodialysis

NIPRO RENAL SOLUTIONS USA CORPORATION

Haemodialysis concentrate

• Primary Device ID: 10817411022401
• NIH Device Record Key: 25ffa9e8-56db-4af3-8345-2af33701f834
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaLyte
• Version Model Number: DB+201-25
• 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: 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	00817411020325 [Previous]
GS1	00817411022404 [Primary]
GS1	10817411022401 [Package]; Contains: 00817411022404; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131202

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 [MedicaLyte]

• 10817411022821: Liquid Bicarbonate Concentrate for Hemodialysis
• 10817411022418: Dry Bicarbonate Powder Concentrate for Hemodialysis
• 10817411022401: Dry Bicarbonate Powder Concentrate for Hemodialysis
• 10817411022395: Dry Bicarbonate Powder Concentrate for Hemodialysis
• 10817411022814: Liquid Bicarbonate Concentrate
• 10817411022807: Dry Bicarbonate Powder Concentrate
• 10817411022791: Dry Bicarbonate Powder Concentrate
• 10817411022784: Dry Bicarbonate Powder Concentrate