Greiner Bio-One Na, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Greiner Bio-One Na, Inc. makes
Greiner Bio-One Na, Inc. manufactures blood collection and infusion sets, including the VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set, designed for safe venipuncture and fluid administration. The company also produces urine collection and culture tubes, such as the VACUETTE Urine Count and Culture Mannitol tube, as well as blood chemistry tubes like the MiniCollect K2E K2EDTA Tubes. Additional products include the VACUETTE SAFELINK Holder and the Greiner Holdex, a tube holder system.
The company’s devices are classified under FDA regulations as Class I and Class II, with relevant products listed via the 510(k) pathway. These products are intended for use in clinical and laboratory settings in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
VACUETTE SAFELINK Holder with male luer lock Ref K180545
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
MiniCollect K2E K2EDTA Tubes Ref K182078
Regimes: 510(k) Registry: 510(k)Greiner Holdex Ref K160532
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Greiner Bio-One Na, Inc. have in the registry?
The registry currently lists 5 devices for Greiner Bio-One Na, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Greiner Bio-One Na, Inc.'s devices?
Among its 5 most recently registered devices, Greiner Bio-One Na, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Greiner Bio-One Na, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Greiner Bio-One Na, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Greiner Bio-One Na, Inc. in the registry?
The most recently registered devices listed for Greiner Bio-One Na, Inc. include VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set, VACUETTE SAFELINK Holder with male luer lock, Greiner Vacuette Urine Count and Culture, Mannitol tube and MiniCollect K2E K2EDTA Tubes.