FDA device listing
15mm Male/Female Adapter,15mm Male/Female Adapter Low Deadspace,AA &TRAY ASSY, ADU, ZOLL MED 8000-0262,Adapter ADU Reuse…
FDA device listing 1976710720 · Philips Medical Systems International BV
Key facts
| Proprietary names | 15mm Male/Female Adapter,15mm Male/Female Adapter Low Deadspace,AA &TRAY ASSY, ADU, ZOLL MED 8000-0262,Adapter ADU Reuse Capnostat 704-0002-00,CapnoTrak Airway Adapter Set,Infant Airway Adapter, Disposable,Neonatal Airway Adapter,Neonatal and Pediatric CO2 Airway Adapter, Disposable,Neonatal/Pediatric Airway Adapter,NOVA DISP AIRW ADPTRADLT 20/C,Pediatric/Adult Airway Adapter,Pediatric/Adult… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Product codes | BZA |
| Device names | BZA - Connector, Airway (Extension) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5810 |
| Review panels | Anesthesiology |
| Registered establishments | Philips Electronics Ltd, Philips Medical Systems Ltda, Philips Medizin Systeme Boeblingen GmbH, RESPIRONICS NOVAMETRIX, LLC |
| Establishment registrations | 1219324, 9610816, 3000126629, 3014541700 |
| FEI numbers | 1219324, 3000126629, 3002807167, 3014541700 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer, Foreign Exporter |
| 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