PRISMAFLEX SET 107140

GUDID 37332414069255

The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

GAMBRO INDUSTRIES

Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter

• Primary Device ID: 37332414069255
• NIH Device Record Key: b11d99eb-a4be-43a9-b1b4-ede34cd4ddce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISMAFLEX SET
• Version Model Number: HF1000
• Catalog Number: 107140
• Company DUNS: 393020474
• Company Name: GAMBRO INDUSTRIES
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414069254 [Primary]
GS1	37332414069255 [Package]; Contains: 07332414069254; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042938

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-30
• Device Publish Date: 2015-10-05

On-Brand Devices [PRISMAFLEX SET]

• 37332414090006: The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the P
• 37332414069316: The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisM
• 37332414069255: The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisM
• 37332414064557: The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the P
• 37332414064540: The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the Pr
• 50085412954108: Disposable extracorporeal circuit
• 50085412954078: Disposable extracorporeal circuit
• 50085412917691: Disposable extracorporeal circuit