FDA device listing
Giraffe and Panda Bag and Mask Resuscitation System,Giraffe Stand-alone Infant Resuscitation System,Giraffe Stand-alone…
FDA device listing 1395478094 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Giraffe and Panda Bag and Mask Resuscitation System,Giraffe Stand-alone Infant Resuscitation System,Giraffe Stand-alone Infant Resuscitation System (Bag and Mask),StAR |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K070247 |
| Product codes | BTM |
| Device names | BTM - Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5915 |
| Review panels | Anesthesiology |
| Registered establishments | Datex-Ohmeda, Inc., GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V., WIPRO GE HEALTHCARE PRIVATE Ltd. |
| Establishment registrations | 3007734888, 3008729547, 3014220748, 3036470679 |
| FEI numbers | 3007734888, 3008729547, 3014220748, 3036470679 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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