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AirTechniques
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 16025Model Baldus Doppelnasenmasken-Scavengersystem
Identity
- Trade Name
- Baldus Doppelnasenmaske, Adult, autoklavierbar EUDAMEDAirTechniques FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMEDTo be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxyg Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood. FDA UDI
- Model / Reference
- Baldus Doppelnasenmasken-Scavengersystem EUDAMED16025 EUDAMEDNHAA101 FDA UDI
- Description
- To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxyg Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260635790103 EUDAMEDFDA UDI
- Basic UDI-DI
- 426063579MASKCG EUDAMED
- Direct Marketing DI
- 04260635790103 EUDAMED
- FDA Product Code
- KHA FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Anaesthesia face mask, reusable
AirTechniques by Baldus Sedation GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
- Nasal Hood For Anesthesia Reusable Large — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Silicone Reusable Adult Size 4 — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5 — FLEXICARE MEDICAL LIMITED · Class I
- REPL SMALL NASAL HOOD — Parker Hannifin Corp. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- REPL MEDIUM NASAL HOOD — Parker Hannifin Corp. · 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 a7083628-39ac-4c15-8101-3db888e7d9fb 33 fields · synced Jul 9, 2026
- EUDAMED 7000b7d6-a0ea-4d80-bdb7-08e9e871fbc4 61 fields · synced Jul 9, 2026