AirTechniques
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Baldus CO2-Adapter EUDAMEDAirTechniques FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMEDThe Double Nasal Hood End-Tidal CO2 Adapter is to be used during a combination sedation of N2O, O2 and a combination drug e.g. Midazolam to give the possibility to connect a capnography device to it. This device shall measure the etCO2 curve of the patient exhaled gases. To be used in nitrous-oxide-oxygen sedation systems. 12 Double Nasal Hood End-Tidal CO2 Adapter wrapped in a box. FDA UDI
- Model / Reference
- Baldus Doppelnasenmasken-Scavengersystem EUDAMED16054-12 EUDAMEDNHCO2-K FDA UDI
- Description
- The Double Nasal Hood End-Tidal CO2 Adapter is to be used during a combination sedation of N2O, O2 and a combination drug e.g. Midazolam to give the possibility to connect a capnography device to it. This device shall measure the etCO2 curve of the patient exhaled gases. To be used in nitrous-oxide-oxygen sedation systems. 12 Double Nasal Hood End-Tidal CO2 Adapter wrapped in a box. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260635790677 EUDAMEDFDA UDI
- Basic UDI-DI
- 426063579MASKCG EUDAMED
- Direct Marketing DI
- 04260635790677 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Anaesthesia breathing circuit, single-use
AirTechniques by Baldus Sedation GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Baldus Sedation GmbH & Co. KG
Sources (2)
- FDA UDI df5bc128-750e-4c10-a9eb-0b04d4051d99 33 fields · synced Jul 23, 2026
- EUDAMED b0970786-b306-4dce-849e-2a643af05f26 61 fields · synced Jul 23, 2026