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AirTechniques

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 16056Model Baldus Doppelnasenmasken-Scavengersystem

by Baldus Sedation GmbH & Co. KG

Identity

Trade Name
Baldus Doppelnasenmasken-Scavengersystem mit Vakuumkontrollblock und Single Use Doppelmasken EUDAMED
AirTechniques FDA UDI
Generic Name
Anaesthesia breathing circuit, reusable FDA UDI
Device Name
Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMED
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, Vacuum Control Block, into the Vacuum System, and exhausted to the outside of the building. 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 EUDAMED
16056 EUDAMED
NSC-VCB 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, Vacuum Control Block, into the Vacuum System, and exhausted to the outside of the building. 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
04260635790516 EUDAMEDFDA UDI
Basic UDI-DI
426063579MASKCG EUDAMED
Direct Marketing DI
04260635790516 EUDAMED
FDA Product Code
CAI FDA UDI
EMDN Code
R030199 RESPIRATORY MASKS - OTHER EUDAMED
GMDN Term
Anaesthesia breathing circuit, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
868.5240 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

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
Sterilization Method
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia breathing circuit, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baldus Sedation GmbH & Co. KG

Sources (2)

  • FDA UDI 7250781a-6d4b-416f-8aaa-13497665a59d 33 fields · synced Jul 14, 2026
  • EUDAMED bc83d21b-ad1b-476a-b406-1ed055eff4c5 61 fields · synced Jul 14, 2026