GREINER BIO-ONE NORTH AMERICA, INC.

FDA Device Registration & Listing · MONROE, NC, US · Registration 1125230

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1125230
FEI Number
3001451379
Entity Name
GREINER BIO-ONE NORTH AMERICA, INC.
City/State/Country
MONROE, NC, US
Establishment Address
4238 Capital Dr, MONROE, NC 28110, US
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
Y
Expiration Date (Year)
2026
510(k) Number
K983952
PMA Number
N/A

All Registered Proprietary Names

Vacuette Blood Collection Tubes K2EDTA VACUETTE Blood Collection Tube K2EDTA VACUETTE Blood Collection Tube K3EDTA Vacuette Blood Collection Tubes K2EDTA VACUETTE Blood Collection Tube Trace Element No Additive VACUETTE Blood Collection Tube Trace Element Sodium Heparin 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 No Additive Vacuette Blood Collection Tubes Serum with Clot Activator and Gel VACUETTE Blood Collection Tube Serum Clot Activator VACUETTE Blood Collection Tube with Sodium Heparin VACUETTE QUICKSHIELD Safety Tube Holder Vacuette Blood Collection Tubes with K3EDTA Vacuette Blood Collection Tubes K3EDTA Vacuette Blood Collection Tubes Serum with Clot Activator and Gel Vacuette Blood Collection Tubes Serum with Clot Activator Vacuette Blood Collection Tubes with K2EDTA Vacuette Blood Collection Tubes Serum Clot Activator Vacuette Blood Collection Tubes No Additive Vacuette Standard Tube Holder (short version) Vacuette Standard Tube Holder (long version) VACUETTE Blood Collection Tubes with Clot Activator and Gel VACUETTE Blood Collection Tubes with Clot Activator

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
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
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
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2008-09-17
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
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
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
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 2007-11-08
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 2006-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
8020040 GREINER BIO-ONE GMBH KREMSMUENSTER Oberosterreich, AT

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

Similar Registrations

Registration Number Establishment Name Location
3024537844 AVIA VASCULAR Salt Lake City, UT, US
3006285950 Labcorp CLS Indianapolis, IN, US
1036836 Sterigenics U.S., LLC Haw River, NC, US
3030626857 PALM MEDICAL INTERNATIONAL BV Buggenhout Oost-Vlaanderen, BE
1423507 CAREFUSION 2200, INC. Vernon Hills, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1125230. Last updated year: 2026. Please use registration number 1125230 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.