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AirTechniques
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 16030-AblueModel Baldus Doppelnasenmasken-Scavengersystem
Identity
- Trade Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Blueberry Dance EUDAMEDAirTechniques FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMEDDouble Nasal Hood Single Use, Adult, Scent Blueberry Dance 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood. FDA UDI
- Model / Reference
- Baldus Doppelnasenmasken-Scavengersystem EUDAMED16030-Ablue EUDAMEDNHA12BD FDA UDI
- Description
- Double Nasal Hood Single Use, Adult, Scent Blueberry Dance 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260635790431 EUDAMEDFDA UDI
- Basic UDI-DI
- 426063579MASKCG EUDAMED
- Direct Marketing DI
- 04260635790431 EUDAMED
- FDA Product Code
- KHA FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia face mask, 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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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 b403d5b4-56c5-4c59-abfd-1650bf25e468 33 fields · synced Jun 19, 2026
- EUDAMED 06f94768-4dc3-4a8d-9810-b0d8047420a6 61 fields · synced Jun 19, 2026