Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020040

FEI Number

3000974732

Entity Name

GREINER BIO-ONE GMBH

City/State/Country

KREMSMUENSTER Oberosterreich, AT

Establishment Address

BAD HALLER STRASSE 32, KREMSMUENSTER Oberosterreich A-4550, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

GREINER BIO-ONE NA (Owner Number: 8020040)

Owner / Operator Contact Address

4238 Capital Drive, Monroe, NC 28110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012043

PMA Number

N/A

All Registered Proprietary Names

Plastic Cannula HOLDEX VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer Device VACUETTE® Urine CCM Tube+Urine Cup with Transfer Device VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Transfer Device VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Cup with Transfer Device VACUETTE Blood Collection Tube Lithium Heparin VACUETTE Blood Collection Tube Lithium Heparin Sep MiniCollect Blood Collection Tube Lithium Heparin MiniCollect Bllod Collection Tube Lithium Heparin Sep HOLDEX Single-Use Holder PP, single-packed Vacuette Blood Collection Tubes No Additive Vacuette Blood Collection Tubes K3EDTA Vacuette Virus Stabilization Tube Phosphate Buffered Saline Tube VACUETTE Safety Blood Collection/Infusion Set VACUETTE Luer Adapter Vacuette Safety Blood Collection / Infusion Set MiniCollect Blood Collection Tubes Z Serum MiniCollect Blood Collection Tubes Z Serum Sep MiniCollect Blood Collection Tubes K3EDTA MiniCollect Tube K2E EDTA K2 MiniCollect Complete K2E EDTA K2 VACUETTE Blood Collection Tube K2EDTA VACUETTE Blood Collection Tube K3EDTA VACUETTE® SAFELINK Holder with male luer lock VACUETTE Urine Beaker MiniCollect Carrier Tubes Vacuette Urine Beaker with Integrated Transfer Device VACUETTE Urine Transfer Device MiniCollect Funnel Blood Transfer Unit Vacuette No Additive Urine Tubes VACUETTE No Additive Tubes VACUETTE Sample Transfer Unit Vacuette Urine STB tubes MiniCollect Capillary Vacuette Blood Collection Tubes Serum Clot Activator Vacuette Blood Collection Tubes No Additive Vacuette Blood Collection Tubes with K3EDTA MiniCollect Blood Collection Tube K2EDTA VACUETTE Urine CCM Tube VACUETTE Urine CCM Tube convenience kit SECONDARY Tubes SIMPLEX SECONDARY Tubes MULTIPLEX Vacuette Urine Transfer Device Urine STB Set Vacuette Quickshield Complete PLUS Safety Tube Holder Vacuette Quickshield Complete Safety Tube Holder Vacuette Blood Culture Holder Vacuette Safety Blood Collection Set plus Luer Adapter with pre-attached Blood Culture Holder VACUETTE Multiple Use Drawing Needle Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2% Vacuette Blood Collection Tubes with K3EDTA Vacuette Blood Collection Tubes K2EDTA Vacuette Blood Collection Tubes Serum with Clot Activator and Gel VACUETTE Blood Collection Tube Serum Clot Activator HOLDEX Single-Use Holder PP, single-packed Vacuette Standard Tube Holder (short version) Vacuette Standard Tube Holder (long version) VACUETTE Blood Collection Tube with Sodium Heparin Vacuette Blood Collection Tubes FE Sodium Fluoride / K3 EDTA Vacuette Blood Collection Tube FX Sodium Fluoride / Potassium Oxalate VACUETTE Blood Collection Tube Trace Element No Additive VACUETTE Blood Collection Tube Trace Element Sodium Heparin Vacuette Blood Collection Tubes with K2EDTA and Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2006-09-15
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2026-01-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-02-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-11-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-03-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-04-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1998-01-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-08-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-02-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-11-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-05-29
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2008-09-17
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2015-01-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-11-08
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2017-03-07
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2017-03-07
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-09-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-11-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-01-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1998-01-13
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2006-04-06
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2006-04-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1998-01-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	1997-06-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2006-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Angela Drysdale Business: GREINER BIO-ONE NORTH AMERICA, INC. Email: angela.drysdale@gbo.com Phone: (704) 7768646

Related Public Records

Same Entity

GREINER BIO-ONE NA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003997691	GREINER BIO-ONE HUNGARY KFT	MOSONMAGYAROVAR Gyor-Moson-Sopron, HU
3007817041	GREINER BIO-ONE GMBH	Rainbach im Muehlkreis Oberosterreich, AT
3005674478	GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR	AMERICANA Sao Paulo, BR
1125230	GREINER BIO-ONE NORTH AMERICA, INC.	MONROE, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020040. Last updated year: 2026. Please use registration number 8020040 when referencing this establishment in official correspondence.