FDA Registration
Active
🇺🇸 United States
STAT MEDICAL DEVICES, INC.
Reg #: 1058955
·
FEI: 1000525253
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- STAT MEDICAL DEVICES, INC.
- Registration Number
- 1058955
- FEI Number
- 1000525253
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2056 NE 153rd St
- City
- North Miami Beach
- State
- FL
- ZIP
- 33162
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223815
Owner / Operator
- Firm Name
- STAT MEDICAL DEVICES, INC.
- Operator Number
- 9020044
- Address
- 2056 NE 153rd Street, --
- City
- North Miami Beach
- State
- FL
- Postal Code
- 33162
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-02-17 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-02-17 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2009-11-16 |
Proprietary Names
ONE Drop Lancing Device
STAT Super-Fine Insulin Pen Needle Standard
STAT Super-Fine Insulin Pen Needle Xtra
STAT Super-Fine Insulin Pen Needle Micro
ULTIMATE Lancing Device
TRIO Lancing Device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility