FDA device listing
K 600 LATEX TUBING,KEP NON STERILE,KEP NON-STERILE,Penrose Drain Non-Sterile,THERMOPLASTIC TUBING
FDA device listing 1063402476 · KENT ELASTOMER PRODUCTS, INC.
Key facts
| Proprietary names | K 600 LATEX TUBING,KEP NON STERILE,KEP NON-STERILE,Penrose Drain Non-Sterile,THERMOPLASTIC TUBING |
|---|---|
| Owner/operator | KENT ELASTOMER PRODUCTS, INC. |
| Owner/operator number | 9044738 |
| Product codes | GBW |
| Device names | GBW - Catheter, Peritoneal |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | KENT ELASTOMER PRODUCTS, INC. |
| Establishment registrations | 3002303166, 3003502083 |
| FEI numbers | 3002303166, 3003502083 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database