FDA.reportPublic FDA data

AirLife™

Primary DI
50190752157246
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
2812F14-25
Catalog number
2812F14-25
Device description
Nasal ETCO2Cannula, Adult with 14’O2tube and 14’CO2tube with female luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752157246PackageGS125In Commercial Distribution
10190752157248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215724650190752157246
1019075215724810190752157248

GMDN Terms#

Term, Definition table
TermDefinition
Basic nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752114791Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062020-01-15
10190752115200AirLife™0020030020032020-01-15
10190752141643Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202021-04-02
10190752129993LTV11581-G11581-G2021-02-22
10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27