FDA device listing
2500ML 24 HR URINE CONTAINER (Cat. No. U3010-1),3000ML 24 HR URINE CONTAINER (Cat. No. U3010-3),3000ML 24 HR URINE…
FDA device listing 1257583983 · Thermo Fisher Scientific
Key facts
| Proprietary names | 2500ML 24 HR URINE CONTAINER (Cat. No. U3010-1),3000ML 24 HR URINE CONTAINER (Cat. No. U3010-3),3000ML 24 HR URINE CONTAINER (Cat. No. U3010-3B),3500ML 24 HR URINE CONTAINER (Cat. No. U3010-2),Andwin Scientific™ Specimen Cup, 90mL, 53mm, NAT Cap, NS (Cat. No. 840100),FISHER 24 HR URINE CONTAINER (Cat. No. 14-375-248),Fisherbrand™ 60mL, 48mm, NS, w/lab and tem strip, WHT Cap (Cat. No. 22 610… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | NNI |
| Device names | NNI - Container, Specimen, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | Nalge Nunc International Corporation, Thermo Fisher Scientific (Monterrey) |
| Establishment registrations | 1314344, 3023443877 |
| FEI numbers | 1000087290, 3023443877 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Specification Developer |
| 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