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 Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser Laboratory dialyser 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