PRISMAFLEX SET 107643US

GUDID 50085412954108

Disposable extracorporeal circuit

GAMBRO INDUSTRIES

Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter

• Primary Device ID: 50085412954108
• NIH Device Record Key: aad6370c-e857-4444-a72b-a864a280ac9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISMAFLEX SET
• Version Model Number: 107643US
• Catalog Number: 107643US
• 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
• 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
• 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	00085412954103 [Primary]
GS1	50085412954108 [Package]; Contains: 00085412954103; Package: CA [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212216

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-30
• Device Publish Date: 2022-11-22

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