FDA device listing
AL-31320-020.V001 - SINGLE LIMB CIRCUIT,AL-31320-020.V002 - J -CIRCUIT,AL-3220-020.V001 - SINGLE LIMB…
FDA device listing 1136123085 · Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
Key facts
| Proprietary names | AL-31320-020.V001 - SINGLE LIMB CIRCUIT,AL-31320-020.V002 - J -CIRCUIT,AL-3220-020.V001 - SINGLE LIMB CIRCUIT,AL-3220-020.V002 - J -CIRCUIT,AL-81390-005.V001 - BPAP CIRCUIT,AL-8290-005/7.V002 - BPAP CIRCUIT,Altech,BC21086 – Standard Breathing Circuit with Face Mask- Infant,BC21087- Standard Breathing Circuit with Face Mask - Toddler,BC21088- Standard Breathing Circuit with Face Mask – Child/ Adult… |
|---|---|
| Owner/operator | Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. |
| Owner/operator number | 9099982 |
| Product codes | CAI |
| Device names | CAI - Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5240 |
| Review panels | Anesthesiology |
| Registered establishments | Meditera Tibbi Malzeme Sanayi ve Ticaret A.S., S & Mohr America, S.A. DE C.V. |
| Establishment registrations | 3006534321, 3020777588 |
| FEI numbers | 3006534321, 3020777588 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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