Data / Medical devices / Brazil / Greiner Bio One Brasil Produtos Medicos Hospitalar
Greiner Bio One Brasil Produtos Medicos Hospitalar: FDA-registered device maker in AMERICANA Sao Paulo, Brazil, 13 510(k) clearances
Greiner Bio One Brasil Produtos Medicos Hospitalar is registered with the FDA (registration 3005674478) in AMERICANA Sao Paulo, Brazil. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 15, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005674478
- Address
- Av. Affonso Pansan, 1967, AMERICANA Sao Paulo, Brazil, 13473-620
- Owner or operator
- GREINER BIO-ONE NA (8020040)
- Roles
- Manufacturer
- First device listed
- June 23, 1997
- Registered through
- 2026
- Brand names listed
- Blood Transfer Unit, MiniCollect Carrier Tubes, MiniCollect Funnel, VACUETTE Blood Collection Tube K2EDTA, VACUETTE Blood Collection Tube K3EDTA, VACUETTE Blood Collection Tube Lithium Heparin, VACUETTE Blood Collection Tube Lithium Heparin Sep, VACUETTE Blood Collection Tube Trace Element No Additive and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood/Plasma Collection Device For Dna Testing | PJE | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2005 | K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | PJE | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| December 29, 2003 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| January 27, 2003 | K023971 | VACUETTE TRACE ELEMENTS TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| February 1, 2002 | K014104 | VACUETTE EDTA K2 TUBES | PJE | Substantially Equivalent | Greiner Vacuette North America, Inc. | accessdata.fda.gov |
| September 24, 2001 | K012043 | VACUETTE EDTA K2 GEL TUBES | PJE | Substantially Equivalent | Greiner Vacuette North America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| December 28, 1998 | K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner Meditech, Inc. | accessdata.fda.gov |
| May 12, 1997 | K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| May 12, 1997 | K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| May 2, 1997 | K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | GIM | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| September 5, 1996 | K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| August 30, 1996 | K960858 | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| August 30, 1996 | K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Container, Specimen, Sterile
- All makers of Tubes, Vacuum Sample, With Anticoagulant
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Blood/Plasma Collection Device For Dna Testing
Updated April 15, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.