FDA Registration
Active
🇺🇸 United States
INNOVATE MEDICAL, LLC
Reg #: 2321034
·
FEI: 3003399884
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- INNOVATE MEDICAL, LLC
- Registration Number
- 2321034
- FEI Number
- 3003399884
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2210 Buffalo Road
- City
- Johnson City
- State
- TN
- ZIP
- 37604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032150
Owner / Operator
- Firm Name
- Innovate Medical, LLC
- Operator Number
- 10028796
- Address
- 2210 Buffalo Road
- City
- Johnson City
- State
- TN
- Postal Code
- 37604
- Country
- US
- Correspondent
- Susan F Johnston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2016-02-14 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2024-02-16 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-07-05 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2024-07-05 |
| Radiology-Diagnostic Kit | OIP | Class 2 | Radiology | No | 2023-01-27 |
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2022-11-29 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2009-03-06 |
| Covid-19 Test Home Collection Kit Devices | QLW | Class N | Unknown | No | 2021-12-29 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-03-06 |
Proprietary Names
INNOVATE MEDICAL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility