PureFlow

GUDID 10840861102775

PureFlow RFP-400

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution

• Primary Device ID: 10840861102775
• NIH Device Record Key: 3df9068e-3178-4479-b40a-7e743951c007
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureFlow
• Version Model Number: RFP-400-W
• Company DUNS: 079732391
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• 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: true
• 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 Dimensions

• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter
• Total Volume: 5000 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102778 [Primary]
GS1	10840861102775 [Package]; Contains: 00840861102778; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233159

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-07
• Device Publish Date: 2024-05-30

On-Brand Devices [PureFlow]

• 10840861102799: PureFlow RFP-401
• 10840861102782: PureFlow RFP-407
• 10840861102775: PureFlow RFP-400
• 10840861102768: PureFlow RFP-402