FDA device listing
Pap Smear Kit
FDA device listing 1532835822 · Cardinal Health 200, LLC
Key facts
| Owner/operator | Cardinal Health 200, LLC |
|---|---|
| Owner/operator number | 9028292 |
| Product codes | OHL |
| Device names | OHL - Pap Smear Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.4530 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | AERO-MED LLC, Cardinal Health 200, LLC, Convertors de Mexico S. de R.L. de C.V |
| Establishment registrations | 1423537, 9616088, 3006191977, 3007329020 |
| FEI numbers | 3001236905, 3002902735, 3006191977, 3007329020 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Repackager/Relabeler, 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