FDA device listing
NeoNatalie Suction,Penguin Irrigating Syringe,Penguin Newborn Suction,Penguin Suction Device
FDA device listing 1426996633 · LAERDAL MEDICAL A/S
Key facts
| Proprietary names | NeoNatalie Suction,Penguin Irrigating Syringe,Penguin Newborn Suction,Penguin Suction Device |
|---|---|
| Owner/operator | LAERDAL MEDICAL A/S |
| Owner/operator number | 9038993 |
| Product codes | KYZ |
| Device names | KYZ - Syringe, Irrigating (Non Dental) |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6960 |
| Review panels | General Hospital |
| Registered establishments | LAERDAL MEDICAL (SUZHOU) CO., LTD. |
| Establishment registrations | 3004993040 |
| FEI numbers | 3004993040 |
| Establishment operations | 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