FDA Registration
Active
🇺🇸 United States
COULMED PRODUCTS GROUP LLC
Reg #: 3015625160
·
FEI: 3015625160
·
Expires 2026
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- COULMED PRODUCTS GROUP LLC
- Registration Number
- 3015625160
- FEI Number
- 3015625160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 44 Commerce Street
- City
- Springfield
- State
- NJ
- ZIP
- 07081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101689
Owner / Operator
- Firm Name
- Coulmed Products Group LLC
- Operator Number
- 10076284
- Address
- 44 Commerce Street
- City
- Springfield
- State
- NJ
- Postal Code
- 07081
- Country
- US
- Correspondent
- Calvin MacDougall
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2022-09-27 |
| Table, Cysto, Non-Electrical | EYH | Class 1 | Gastroenterology, Urology | No | 2024-06-27 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-01-04 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2022-09-27 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2022-09-22 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-10-18 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2022-09-27 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2025-01-15 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2022-09-27 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2022-09-27 |
Proprietary Names
Coulmed Products
Establishment Types
Repack or Relabel Medical Device