FDA device listing
CSS7100 GUARDIAN REAL-TIME MONITOR,CSS7100k GUARDIAN REAL-TIME MONITOR,CSS72 Guardian REAL-Time Continuous Glucose…
FDA device listing 1119875627 · Medtronic
Key facts
| Proprietary names | CSS7100 GUARDIAN REAL-TIME MONITOR,CSS7100k GUARDIAN REAL-TIME MONITOR,CSS72 Guardian REAL-Time Continuous Glucose Monitoring System,MMT-522k PARADIGM REAL-time Pump,MMT-522 PARADIGM REAL-time Pump,MMT-523k Paradigm REAL-Time Revel Insulin Pump,MMT-523 Paradigm REAL-Time Revel Insulin Pump,MMT-523 Paradigm Real-Time Revel Insulin Pump 1.8m,MMT-551 MINIMED 530G INSULIN PUMPS,MMT-7008 ENLITE GLUCOSE… |
|---|---|
| Owner/operator | Medtronic |
| Owner/operator number | 10094334 |
| Premarket submissions | P980022 |
| Product codes | MDS, OYC |
| Device names | MDS - Sensor, Glucose, Invasive, OYC - Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MDS, ORCA1.OYC |
| Review panels | Clinical Chemistry |
| Registered establishments | MEDTRONIC MINIMED, MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS |
| Establishment registrations | 2032227, 3042027705 |
| FEI numbers | 3003166194, 3042027705 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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