MedicaLyte

GUDID 10817411022791

Dry Bicarbonate Powder Concentrate

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 Haemodialysis concentrate Haemodialysis concentrate

• Primary Device ID: 10817411022791
• NIH Device Record Key: 5da35125-2475-4475-967f-f2b48a9f7bba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedicaLyte
• Version Model Number: DB+100-15
• 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	00817411022794 [Primary]
GS1	10817411022791 [Package]; Contains: 00817411022794; Package: Case [3 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: 2022-02-25
• Device Publish Date: 2022-02-17

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