FDA device listing
ADULT NASAL CANNULA WITH TUBING,ADULT NASAL CANNULA W/O TUBING,ADULT SOFT NASAL CANNULA WITH TUBING,Auto Chamber…
FDA device listing 1067917698 · GaleMed Corporation
Key facts
| Proprietary names | ADULT NASAL CANNULA WITH TUBING,ADULT NASAL CANNULA W/O TUBING,ADULT SOFT NASAL CANNULA WITH TUBING,Auto Chamber, Infant,C22 Star Lumen Tubing, 1000cm,C22 Star Lumen Tubing, 200cm, 6M,C23 Star Lumen Tubing, 200cm, 6M,Flare Nasal Cannula, Adult,Flow Indicator w/tubing, 160cm,Flow Indicator w/tubing, 200cm,Nasal oxygen cannula,NEONATE SOFT NASAL CANNULA WITH TUBING,NHF Prong Kit, #2,NHF Prong Kit… |
|---|---|
| Owner/operator | GaleMed Corporation |
| Owner/operator number | 8043316 |
| Product codes | CAT |
| Device names | CAT - Cannula, Nasal, Oxygen |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5340 |
| Review panels | Anesthesiology |
| Registered establishments | GALEMED CORP., GaleMed (Xiamen) Co., Ltd. |
| Establishment registrations | 8043316, 3006783791 |
| FEI numbers | 3003319165, 3006783791 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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