FDA.reportPublic FDA data

AirTechniques

Primary DI
04260635790707
Brand
AirTechniques
Company
Baldus Sedation GmbH & Co. KG
Model
NSP0030
Device description
To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxyg.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260635790707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260635790707042606357907074260635790707

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, reusableAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343104962
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260635790660AirTechniquesNFT60002026-05-11
04260635790776AirTechniquesNFA400052026-05-11
04260635790783AirTechniquesNFA40002026-05-11
04260635790790AirTechniquesNFT65002026-05-11
04260635790431AirTechniquesNHA12BD2023-01-05
04260635790523AirTechniquesNHA12BB2023-01-05
04260635790547AirTechniquesNHA12HA2023-01-05
04260635790677AirTechniquesNHCO2-K2023-01-05
04260635790448AirTechniquesNHA12SD2023-01-05
04260635790479AirTechniquesNHP12BD2023-01-05
04260635790486AirTechniquesNHP12SD2023-01-05
04260635790530AirTechniquesNHP12BB2023-01-05
04260635790554AirTechiquesNHA12PG2023-01-05
04260635790578AirTechniquesNHP12CV2023-01-05
04260635790585AirTechniquesNHA12CV2023-01-05
04260635790592AirTechniquesNHP12HA2023-01-05
04260635790608AirTechniquesNHP12PG2023-01-05
04260635790103AirTechniquesNHAA1012022-12-02
04260635790158AirTechniquesNHAP1012022-12-02
04260635790493AirTechniquesNH-KIT2022-12-02

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00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
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