Vivafree 2

GUDID 05060602430167

This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.

SARTORIUS STEDIM LAB LIMITED

Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD, non-sterile Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD Centrifuge tube IVD
Primary Device ID05060602430167
NIH Device Record Keyebb386b8-1e71-4e5c-ae81-3ab386cfeb24
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivafree 2
Version Model NumberVFR02H21
Company DUNS345881551
Company NameSARTORIUS STEDIM LAB LIMITED
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060602430167 [Primary]
GS105060602430389 [Unit of Use]

FDA Product Code

JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-25
Device Publish Date2020-08-17

On-Brand Devices [Vivafree 2]

05060602430211This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430204This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430198This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430181This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430174This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430167This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use

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