Blood Specimen Collection Devices - Vacuum
Greiner Bio-One GmbH
GREINER BIO-ONE GMBH
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007817041 | 3007817041 | GREINER BIO-ONE GMBH | 1 | N | 2026-01-01 | Gewerbepark 2 Rainbach im Muehlkreis Oberosterreich AT 4261 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 107126 | 1716324716 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | FMI | 2018-04-19 |
| 107126 | 1652122978 | K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | FMI | 2007-09-14 |
| 107126 | 1375765896 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | 2003-12-29 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FMI | 3 | 2018-04-19 |
PMN
Blood Specimen Collection Devices - Vacuum
Greiner Bio-One GmbH
GUDID
VACUETTE - Urine CCM / Z Urine Set VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Cup with Transfer Device (454486+455028+724321)
2026-01-26
VACUETTE - Urine CCM / Urine Cup Set VACUETTE® Urine CCM Tube+Urine Cup with Transfer Device (454486+724321)
2026-01-26
VACUETTE - Urine CCM / Z Urine Set VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Transfer Device (454486+455028+450751)
2026-01-26
VACUETTE - Urine CCM / Urine STB Set VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer Device (454486+455023+724321)
2026-01-26
VACUETTE - Urine STB Set VACUETTE® Urine STB Tube + Urine Transfer Device (455023+450751), single-packed, conical base, 9 ml, 16x100
2025-04-02
Vacuette - VACUETTE® TUBE 6 ml Urine STB 13x100 yellow cap-red ring, Round Base, non-ridged
2025-03-25
Vacuette - VACUETTE® TUBE 9.5 ml Urine STB 16x100 yellow cap-red ring, Round Base, non-ridged
2025-03-25
Vacuette - VACUETTE® TUBE 9 ml Urine STB 16x100 yellow cap-red ring, Conical Base, non-ridged
2025-03-25
VACUETTE - Urine Cup with integrated Transfer Device 100 ml 10 pcs./bag, sterile
2024-07-23
VACUETTE - VACUETTE® TUBE 8.5 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
2024-07-02
VACUETTE - VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, G-barcode label, non-ridged
2024-05-14
VACUETTE - VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, G-barcode label, non-ridged
2024-05-14
VACUETTE - VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, G-barcode label, non-ridged
2024-05-14
Vacuette - VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, G-barcode label, PREMIUM
2023-12-15
Vacuette - VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring, sandwich tube, G-barcode label, PREMIUM
2023-12-15
Vacuette - VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, G-barcode label, PREMIUM
2023-12-15
Vacuette - SAFETY Blood Collection Set + Holder 23G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex
2023-12-11
Vacuette - SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Luer Adapter 23G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Luer Adapter 23G x 3/4" tubing length 4" (10 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Luer Adapter 23G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Luer Adapter 25G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection/Infusion Set 25G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection/Infusion Set 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection/Infusion Set 23G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Holder 23G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Holder 21G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - SAFETY Blood Collection Set + Holder 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
2023-12-07
Vacuette - VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x100 mint green cap-yellow ring, non-ridged
2023-10-20
Vacuette - VACUETTE® TUBE 2.5 ml Z No Additive 13x75 white cap-black ring, non-ridged, USA
2023-08-11
Vacuette - VACUETTE® SECONDARY Tube MULTIPLEX PET 13x75 mm without cap, non-ridged
2023-08-04
Vacuette - Urine Cup with integrated Transfer Device 100 ml bulk-packed, sterile
2022-06-18
Vacuette - Urine Cup with integrated Transfer Device 100 ml bulk-packed, non-sterile
2022-06-18
Vacuette - Urine Beaker with Safety Stopper 100 ml, white lid single-packed, sterile
2020-10-05
VACUETTE - VACUETTE® VISIO PLUS Needle 21G x 1 1/4" green, sterile, not made with natural rubber latex 0.8 x 32 mm
2021-11-23
VACUETTE - VACUETTE® VISIO PLUS Needle 22G x 1 1/4" black, sterile, not made with natural rubber latex 0.7 x 32 mm
2021-11-17
Vacuette - VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM
2020-06-08
Vacuette - VACUETTE® TUBE 3 ml 9NC Coagulation sodium citrate 3,8% 13x75 blue cap-black ring, sandwich tube, PREMIUM
2021-05-07
Vacuette - VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA
2021-01-14