FDA.reportPublic FDA data

Vivapore 5

Primary DI
05060602430129
Brand
Vivapore 5
Company
SARTORIUS STEDIM LAB LIMITED
Model
VP0501
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.
Published
2020-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060602430129PrimaryGS10
05060602430365Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060602430129050606024301295060602430129
05060602430365050606024303655060602430365

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory dialyserA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16318708528Michael.Vagell@Sartorius.com

Regulatory Flags#

DUNS number
345881551
Device count
30
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060602430150Centrisart 113269---------E2020-08-17
05060602430297Vivaspin 4VS04032020-08-17
05060602430303Vivaspin 4VS04042020-08-17
05060602430471Vivaspin Filtrate13269----------E2023-01-04
05060602430488Vivaspin Filtrate13269----------E2023-01-04
05060602430051Vivaspin Turbo 4VS04T01IVD2020-08-17
05060602430068Vivaspin Turbo 4VS04T02IVD2020-08-17
05060602430099Vivapore 10/20VP20012020-08-17
05060602430105Vivapore 10/20VP20022020-08-17
05060602430112Vivapore 10/20VP20032020-08-17
05060602430136Vivapore 5VP05022020-08-17
05060602430143Vivapore 5VP05032020-08-17
05060602430310Vivaspin 6VS0603VP2020-08-17
05060602430013Vivaspin 20VS2001IVD2020-08-17
05060602430020Vivaspin 20VS2002IVD2020-08-17
05060602430037Vivaspin 6 VS0601IVD2020-08-17
05060602430044Vivaspin 6VS0602IVD2020-08-17
05060602430075Vivaspin Turbo 15VS15T01IVD2020-08-17
05060602430082Vivaspin Turbo 15VS15T02IVD2020-08-17
05060602430167Vivafree 2VFR02H212020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122899TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07