AirTechniques

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 16050Model Baldus Doppelnasenmasken-Scavengersystem

by Baldus Sedation GmbH & Co. KG

Identity

Trade Name: Baldus Sample Package Doppelnasenmasken Single Use, 1x Adult Blueberry Dance und 1x Pediatric Strawberry Delight EUDAMED
AirTechniques FDA UDI
Generic Name: Anaesthesia face mask, single-use 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. FDA UDI
Model / Reference: Baldus Doppelnasenmasken-Scavengersystem EUDAMED
16050 EUDAMED
NH-KIT 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: 04260635790493 EUDAMEDFDA UDI
Basic UDI-DI: 426063579MASKCG EUDAMED
Direct Marketing DI: 04260635790493 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 EUDAMED
Class I FDA UDI
Regulation Number: 868.5590 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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

Similar devices

Also classified as Anaesthesia face mask, single-use.

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Vital Signs™ — Airlife, Inc. · Class I
Ventlab — Ventlab Corp. · Class I
Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
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 404066e8-4b0a-4b8b-afd2-e4dbeadce3d1 33 fields · synced Aug 2, 2026
EUDAMED 2f49db0d-2cf8-44d3-8518-40ebb943113f 61 fields · synced Aug 2, 2026