Vivapore 10/20

Basic Information

• Brand Name: Vivapore 10/20
• Primary DI: 05060602430099
• Version / Model: VP2001
• Company Name: SARTORIUS STEDIM LAB LIMITED
• Labeler DUNS: 345881551
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 2
• Public Version Date: 2022-02-11
• Public Version Status: Update
• Public Device Record Key: 4e9986a9-4bd4-4fb9-ac3e-627f43e5aefc

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47062	Laboratory dialyser	A device designed to perform dialysis in laboratory samples, a procedure that combines the separation of molecules with different characteristics through a semi-permeable membrane (diffusion) and the simultaneous movement of fluid through the membrane under imposed pressure gradients (ultrafiltration). The device typically consists of a container for the solution to be dialysed (e.g., serum, urine), a container for the solution that performs the dialysis (i.e., dialysate), and a semi-permeable membrane separating them. It is used in clinical laboratories for several procedures such as cerebrospinal fluid concentration, and electrophoresis and chromatography sample preparation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060602430099	GS1
Unit of Use	05060602430358	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius