Vivapore 10/20

GUDID 05060602430112

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.

SARTORIUS STEDIM LAB LIMITED

Laboratory dialyser

• Primary Device ID: 05060602430112
• NIH Device Record Key: 8db42c65-3876-4358-997e-55d09401dc5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivapore 10/20
• Version Model Number: VP2003
• Company DUNS: 345881551
• Company Name: SARTORIUS STEDIM LAB LIMITED
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com
• Phone: +16318708528
• Email: Michael.Vagell@Sartorius.com

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
• 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	05060602430112 [Primary]
GS1	05060602430358 [Unit of Use]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2020-08-25
• Device Publish Date: 2020-08-17

On-Brand Devices [Vivapore 10/20]

• 05060602430112: The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly
• 05060602430105: The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly
• 05060602430099: The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly