FDA device listing
4502 - Waste Bag System with Dual Check Valve Bonded,4512 ¿ Waste Bag System with Dual Check Vale and Macro Drip ¿…
FDA device listing 1640200399 · Procedure Products, Inc.
Key facts
| Proprietary names | 4502 - Waste Bag System with Dual Check Valve Bonded,4512 ¿ Waste Bag System with Dual Check Vale and Macro Drip ¿ Bonded or Attachable,4559 ¿ Waste Bag System with Dual Check Valve Attachable,4571 ¿ Waste Bag System and Stopcock with Dual Check Valve ¿ Bonded/Attachable,4801 ¿ 1000cc/ml or above waste bag w/ male lock,4803 ¿ 1000cc/ml or above waste bag with female lock,4822 ¿ Waste Bag with dual… |
|---|---|
| Owner/operator | Procedure Products, Inc. |
| Owner/operator number | 3020778 |
| Premarket submissions | K874037 |
| Product codes | DQO |
| Device names | DQO - Catheter, Intravascular, Diagnostic |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1200 |
| Review panels | Cardiovascular |
| Registered establishments | PROCEDURE PRODUCTS, INC. |
| Establishment registrations | 3020778 |
| FEI numbers | 3020778 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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