AirTechniques
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Baldus Vakuumkontrollblock EUDAMEDAirTechniques FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMEDTo be used in nitrous-oxide-oxygen sedation systems. The Vacuum Control Block is a safety feature and is used to monitor and precisely adjust the vacuum/suction levels. FDA UDI
- Model / Reference
- Baldus Doppelnasenmasken-Scavengersystem EUDAMED16002Y EUDAMEDNSP0010 FDA UDI
- Description
- To be used in nitrous-oxide-oxygen sedation systems. The Vacuum Control Block is a safety feature and is used to monitor and precisely adjust the vacuum/suction levels. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260635790691 EUDAMEDFDA UDI
- Basic UDI-DI
- 426063579MASKCG EUDAMED
- Direct Marketing DI
- 04260635790691 EUDAMED
- FDA Product Code
- CAX FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2340 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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: Ventilator breathing circuit, reusable
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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Also classified as Ventilator breathing circuit, reusable.
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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 c9d48e16-4455-4d2e-9216-c4c67181b0d5 33 fields · synced Jun 19, 2026
- EUDAMED 37328ad3-ded1-4e45-9eba-8eecaf3c6c25 61 fields · synced Jun 19, 2026