STAT Medical Device Lancing System
Stat Medical Devices
STAT MEDICAL DEVICES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1058955 | 1000525253 | STAT MEDICAL DEVICES, INC. | 1 | Y | 2026-01-01 | 2056 NE 153rd St North Miami Beach FL US 33162 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 50831 | 1014689398 | K230310 | STAT Medical Device Lancing System | QRK | 2023-09-08 |
| 50831 | 1522891970 | K223815 | ONE DROP Lancing Device | QRK | 2023-02-15 |
| 50831 | 1540490500 | K092016 | SUPER-FINE PEN NEEDLE | FMI | 2009-10-02 |
| 50831 | 1384684693 |
Product Codes Associated With Registrations#
PMN#
EasyTouch Lancing Device
Stat Medical Devices
ONE DROP Lancing Device
Stat Medical Devices
SUPER-FINE PEN NEEDLE
STAT MEDICAL DEVICES, INC.
GUDID#
STAT Medical Devices - The Disposable Safety Lancet is intended for capillary blood sampling.
2024-01-04
STAT Medical Devices - The Disposable Safety Lancet is intended for capillary blood sampling.
2024-01-04
STAT Medical Devices - The reusable lancing device is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancing device is to be used with single-use lancets.
2023-11-28
STAT Medical Devices - The Disposable Safety Lancet is intended for capillary blood sampling.
2023-11-28
STAT Medical Devices - The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
2023-11-28
STAT Medical Devices - The Disposable Safety Lancet is intended for capillary blood sampling.
2023-11-28
STAT Medical Devices - The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
2023-11-28
STAT Medical Devices - TRIO Lancing Device
2023-11-16