Vivaspin 4

GUDID 05060602430280

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
Primary Device ID05060602430280
NIH Device Record Key8758e0fd-c27f-4faf-954d-9fe2d1209929
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivaspin 4
Version Model NumberVS0405
Company DUNS345881551
Company NameSARTORIUS STEDIM LAB LIMITED
Device Count500
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

Customer Support Contacts

Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com
Phone+16318708528
EmailMichael.Vagell@Sartorius.com

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
GS105060602430280 [Primary]
GS105060602430402 [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 [Vivaspin 4]

05060602430303This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430297This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use
05060602430280This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.