FDA device listing
Getinge Assured Bowie-Dick Test Card,Green Card Bowie-Dick Test Card
FDA device listing 2039613809 · Getinge
Key facts
| Proprietary names | Getinge Assured Bowie-Dick Test Card,Green Card Bowie-Dick Test Card |
|---|---|
| Owner/operator | Getinge |
| Owner/operator number | 9057664 |
| Premarket submissions | K024293 |
| Product codes | JOJ |
| Device names | JOJ - Indicator, Physical/Chemical Sterilization Process |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2800 |
| Review panels | General Hospital |
| Registered establishments | STERITEC PRODUCTS MFG. CO., INC. |
| Establishment registrations | 2028456 |
| FEI numbers | 1000125215 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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