FDA device listing
Infinity® Acute Care System (IACS)
FDA device listing 1687501502 · Draeger Medical Systems, Inc.
Key facts
| Proprietary names | Infinity® Acute Care System (IACS) |
|---|---|
| Owner/operator | Draeger Medical Systems, Inc. |
| Owner/operator number | 9070398 |
| Premarket submissions | K260579 |
| Product codes | BZQ, CCK, DPS, DQA, DQE, DRT, DSA, DSB, DSF, DSI, DSK, DXG and 5 more |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DQE - Catheter, Oximeter, Fiber-Optic, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSA - Cable, Transducer And Electrode, Patient, (Including Connector), DSB - Plethysmograph, Impedance, DSF - Recorder, Paper Chart, DSI - Detector And Alarm, Arrhythmia, DSK - Computer, Blood-Pressure, DXG - Computer, Diagnostic, Pre-Programmed, Single-Function and 5 more |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1025, 870.1110, 870.1130, 870.1230, 870.1435, 870.2300, 870.2340, 870.2700, 870.2770, 870.2810 and 2 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | DRAEGER MEDICAL SYSTEMS, INC. |
| Establishment registrations | 3005783425 |
| FEI numbers | 3005783425 |
| 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