Ameriflo Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Ameriflo Corp. makes
Ameriflo Corp. manufactures urinary drainage and catheterization devices, including intermittent catheters (e.g., FLO-RITE, SIMPULSE, SIMPULSE II) and a closed-drainage system (NUMATIX) designed for bladder management.
Their products are classified as Class II medical devices under FDA regulations, with pre-market notifications (510(k)) required for individual models. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Flo-Rite Ref K041057
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ameriflo Corp. have in the registry?
The registry currently lists 2 devices for Ameriflo Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ameriflo Corp.'s devices?
Among its 2 most recently registered devices, Ameriflo Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ameriflo Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ameriflo Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ameriflo Corp. in the registry?
The most recently registered devices listed for Ameriflo Corp. include FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 and FLO-RITE.