FDA.reportPublic FDA data

Vacuette

Primary DI
29120017571982
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
456067
Catalog number
456067
Device description
VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 pink cap-black ring, transparent label, non-ridged, USA
Published
2016-09-23
Public version status
Update
Distribution status
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
BK030001000
BK040018000
K042927000
K960860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK030001000
BK040018000
K042927000VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North America2005-04-15PJE
K960860000GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3Greiner America, Inc.1996-09-05JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017571989PackageGS124In Commercial Distribution
29120017571982PrimaryGS10
19120017571985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757198939120017571989
2912001757198229120017571982
1912001757198519120017571985

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K3EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. 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
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
29120017576444VacuetteGreiner Bio-One GmbHPJE2016-09-23