FDA device listing
RAD-SURE 15 Gy,RAD-SURE 25 Gy,RAD-SURE 25 Gy NBF,RAD-SURE Chromicvue 15 Gy,RAD-SURE Chromicvue 25 Gy,RAD-SURE Chromicvue…
FDA device listing 1788004049 · Ashland Specialty Ingredients, G.P.
Key facts
| Proprietary names | RAD-SURE 15 Gy,RAD-SURE 25 Gy,RAD-SURE 25 Gy NBF,RAD-SURE Chromicvue 15 Gy,RAD-SURE Chromicvue 25 Gy,RAD-SURE Chromicvue XR 15 Gy,RAD-SURE Chromicvue XR 25 Gy,RAD-SURE XR 15 Gy,RAD-SURE XR 25 Gy,RAD-SURE XR 25 Gy NBF |
|---|---|
| Owner/operator | Ashland Specialty Ingredients, G.P. |
| Owner/operator number | 9001242 |
| Premarket submissions | BK910018 |
| Product codes | KSS |
| Device names | KSS - Supplies, Blood-Bank |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.9050 |
| Review panels | Hematology |
| Registered establishments | ASHLAND SPECIALTY INGREDIENTS, G.P. |
| Establishment registrations | 2247045 |
| FEI numbers | 1000122243 |
| Establishment operations | Manufacturer, Specification Developer |
| 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