PureFlow

GUDID 10840861102775

PureFlow RFP-400

Fresenius Medical Care Renal Therapies Group, LLC

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