Vivaspin Filtrate

GUDID 05060602430488

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
Primary Device ID05060602430488
NIH Device Record Key3fd762d6-1f59-4910-81f4-c6fcea263066
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivaspin Filtrate
Version Model Number13269----------E
Company DUNS345881551
Company NameSARTORIUS STEDIM LAB LIMITED
Device Count12
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060602430471 [Primary]
GS105060602430488 [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 Date2023-01-12
Device Publish Date2023-01-04

Devices Manufactured by SARTORIUS STEDIM LAB LIMITED

05060602430488 - Vivaspin Filtrate2023-01-12This 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.
05060602430488 - Vivaspin Filtrate2023-01-12 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430013 - Vivaspin 202020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430020 - Vivaspin 202020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430037 - Vivaspin 6 2020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430044 - Vivaspin 62020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430051 - Vivaspin Turbo 42020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430068 - Vivaspin Turbo 42020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum
05060602430075 - Vivaspin Turbo 152020-08-25 This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum

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