FDA Registration
Active
🇺🇸 United States
ECOMED SOLUTIONS, LLC
Reg #: 3010934635
·
FEI: 3010934635
·
Expires 2026
Products
13
Proprietary Names
2
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- ECOMED SOLUTIONS, LLC
- Registration Number
- 3010934635
- FEI Number
- 3010934635
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2910 Falling Waters Blvd
- City
- Lindenhurst
- State
- IL
- ZIP
- 60046
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170234
Owner / Operator
- Firm Name
- Ecomed Solutions, LLC
- Operator Number
- 10049951
- Address
- 2910 Falling Waters Blvd
- City
- Lindenhurst
- State
- IL
- Postal Code
- 60046
- Country
- US
- Correspondent
- David A Yurek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2023-10-09 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-01-08 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-01-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-01-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-06-05 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2024-03-25 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2016-06-21 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2020-02-11 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2015-09-11 |
| Reservoir, Blood, Cardiopulmonary Bypass, Exempt | PTN | Class 2 | Cardiovascular | No | 2017-11-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2025-11-25 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-04-20 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2024-06-05 |
Proprietary Names
Sureglide
HEMAsavR
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device