Identity
- Trade Name
- AirTechniques FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Double Nasal Hood Single Use, Pediatric, Scent Happy Apple 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
- NHP12HA FDA UDI
- Description
- Double Nasal Hood Single Use, Pediatric, Scent Happy Apple 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
- 04260635790592 FDA UDI
- FDA Product Code
- KHA FDA UDI
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5590 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 29040a51-6fe4-4176-beaa-3280355343ec 33 fields · synced May 30, 2026