FDA.reportPublic FDA data

Vacuette

Primary DI
29120049204568
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
455040P
Catalog number
455040P
Device description
VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 lavender cap-yellow ring, non-ridged, USA
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PJEBlood/plasma collection device for DNA testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJEBlood/Plasma Collection Device For Dna TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012043000VACUETTE EDTA K2 GEL TUBESGreiner Vacuette North America, Inc.2001-09-24PJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120049204565PackageGS124Not in Commercial Distribution
29120049204568PrimaryGS10
19120049204561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912004920456539120049204565
2912004920456829120049204568
1912004920456119120049204561

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/separatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
303639066
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120126131421VACUETTE4530494530492026-01-26
19120126131407VACUETTE4530474530472026-01-26
19120126131414VACUETTE4530484530482026-01-26
19120126131469VACUETTE4530464530462026-01-26
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120017577656Vacuette4588154588152020-09-24
19120126131452VACUETTE4530454530452025-04-02
29120126131459VACUETTE4530454530452025-04-02
29120049209310Vacuette4560084560082025-03-25
29120049209327Vacuette4550244550242025-03-25
29120049209334Vacuette4550234550232025-03-25
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
19120126131001VACUETTE7243257243252024-07-23
29120126131008VACUETTE7243257243252024-07-23
29120049204605Vacuette455232P455232P2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
29120017577175VacuetteGreiner Bio-One GmbHPJE2023-12-15
04038917127677S-Monovette®Sarstedt Aktiengesellschaft & Co.KGPJE2019-09-17
04038917312707S-Monovette®Sarstedt Aktiengesellschaft & Co.KGPJE2018-10-11
29120017571876VacuetteGreiner Bio-One GmbHPJE2017-04-20
39120017571873VacuetteGreiner Bio-One GmbHPJE2017-04-20
29120017571425VacuetteGreiner Bio-One GmbHPJE2017-03-06
39120017571422VacuetteGreiner Bio-One GmbHPJE2017-03-06
29120017570855VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017570862VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571029VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571098VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571166VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571210VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571241VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571296VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571487VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571708VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571852VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571937VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571982VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571999VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017572064VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017575683VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017575843VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576284VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576345VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576352VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576369VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576406VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576413VacuetteGreiner Bio-One GmbHPJE2016-09-23