FDA.reportPublic FDA data

Vacuette

Primary DI
39120017579923
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
454209CA
Catalog number
454209CA
Device description
VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged, Canada
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
BK030032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK030032000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017579923PackageGS124In Commercial Distribution
29120017579926PrimaryGS10
19120017579929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757992339120017579923
2912001757992629120017579926
1912001757992919120017579929

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303639066
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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