FDA.reportPublic FDA data

AirTechniques

Primary DI
04260635790523
Brand
AirTechniques
Company
Baldus Sedation GmbH & Co. KG
Model
NHA12BB
Device description
Double Nasal Hood Single Use, Adult, Scent Bouncy Bubble12 Hoods individually wrapped in a box.To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Published
2023-01-05
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
KHAMask, Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260635790523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260635790523042606357905234260635790523

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

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

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
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
04260635790516AirTechniquesNSC-VCB2022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFFPARKER-HANNIFIN CORPORATIONKHA2026-02-23
00810339030315SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031121SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339030322SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031138SAFE DENTBGSS Company Inc.KHA2024-05-15
00813830027464Axess CapnographyAdaptersACCUTRON, INC.KHA2023-09-22
D974BSIBL011BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL021BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL012BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL022BritedentBright Supply, Inc.KHA2023-09-18
D1243I50NE0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
D1243I50TC0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
04260635790431AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790547AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790448AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790479AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790486AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790530AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790554AirTechiquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790578AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790585AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790592AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790608AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
16975316480031BESTARWUHAN BESTAR INDUSTRY CO.,LTDKHA2022-12-19
06933192201112Hakuna MatataFUJIAN BBC INCKHA2022-12-07
00816711020769Matrx Scavenger Large Nasal InhalerPARKER-HANNIFIN CORPORATIONKHA2022-12-06
04260635790103AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790158AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790493AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790714AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02