Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005674478

FEI Number

3005674478

Entity Name

GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR

City/State/Country

AMERICANA Sao Paulo, BR

Establishment Address

AV. AFFONSO PANSAN, 1967, AMERICANA Sao Paulo 13473-620, BR

Establishment Type(s)

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

BK040066

PMA Number

N/A

All Registered Proprietary Names

VACUETTE Blood Collection Tubes with Clot Activator and Gel VACUETTE Blood Collection Tubes with Clot Activator VACUETTE QUICKSHIELD Safety Tube Holder Vacuette Blood Collection Tubes with K3EDTA VACUETTE Blood Collection Tube K2EDTA VACUETTE Blood Collection Tube K3EDTA Vacuette Blood Collection Tubes with K3EDTA 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 Vacuette Blood Collection Tubes with K2EDTA and Gel VACUETTE Blood Collection Tube Trace Element No Additive VACUETTE Blood Collection Tube Trace Element Sodium Heparin Vacuette Blood Collection Tubes K3EDTA Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2% Vacuette Blood Collection Tubes K2EDTA Vacuette Blood Collection Tubes Serum Clot Activator Vacuette Blood Collection Tubes No Additive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-04-06
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	2007-11-08
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2006-04-06
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2008-09-17
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
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	1997-06-23

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
8020040	GREINER BIO-ONE GMBH	KREMSMUENSTER Oberosterreich, AT
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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 3005674478. Last updated year: 2026. Please use registration number 3005674478 when referencing this establishment in official correspondence.