AccessGUDID - DEVICE: Vivapore 5 (05060602430143)

GUDID

Device Identifier (DI) Information

Brand Name: Vivapore 5
Version or Model: VP0503
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARTORIUS STEDIM LAB LIMITED

Primary DI Number: 05060602430143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 345881551 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8222b79c-bcd6-46d4-a38c-017750b77660
Public Version Date: February 11, 2022
Public Version Number: 2
DI Record Publish Date: August 17, 2020