Data / Medical devices / United States / Coulmed Products Group LLC
Coulmed Products Group LLC: FDA-registered device maker in Springfield, NJ, United States, 1 510(k) clearance
Coulmed Products Group LLC is registered with the FDA (registration 3015625160) in Springfield, NJ, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 20, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015625160
- Address
- 44 Commerce Street, Springfield, NJ, United States, 07081
- Owner or operator
- Coulmed Products Group LLC (10076284)
- Roles
- Repackager or relabeler
- First device listed
- January 4, 2022
- Registered through
- 2026
- Brand names listed
- Coulmed Products
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgical Table Cushion | LWG | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Table, Cysto, Non-Electrical | EYH | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Table Cushion
- All makers of Drape, Surgical, Antimicrobial
- All makers of Table And Attachments, Operating-Room
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
- All makers of Support, Patient Position
- All makers of System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
Updated September 20, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.