Identity
- Trade Name
- AirTechniques FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- 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. To remove the exhaled gases from the patient, through the Exhalation Membrane, Outer Hood, Vacuum Tube, into the Vacuum System, and exhausted to the outside of the building. FDA UDI
- Model / Reference
- NSC-001 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. To remove the exhaled gases from the patient, through the Exhalation Membrane, Outer Hood, Vacuum Tube, into the Vacuum System, and exhausted to the outside of the building. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260635790721 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
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, single-useAnaesthesia breathing circuit, reusable
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 33385d30-9a46-4a2c-9bca-3a0ff0bb84d9 33 fields · synced May 30, 2026