FDA.reportPublic FDA data

AirTechniques

Primary DI
04260635790721
Brand
AirTechniques
Company
Baldus Sedation GmbH & Co. KG
Model
NSC-001
Device 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.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
04260635790721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260635790721042606357907214260635790721

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
Kit
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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Primary DI, Brand, Company table
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08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
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10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
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