FDA.reportPublic FDA data

AirLife™

Primary DI
10889483569351
Brand
AirLife™
Company
AIRLIFE
Model
001212
Catalog number
001212
Device description
AirLife™ Adult Oxygen Mask Vinyl, Under-the-Chin Style, High Concentration Nonrebreather Mask Without Safety Vent, With 7 feet (2.1 m) Supply Tubing
Published
2025-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483569355PackageGS150In Commercial Distribution
10190752116405PreviousGS10
10889483569351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948356935530889483569355
1019075211640510190752116405
1088948356935110889483569351

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950293Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874950750Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951016Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951344Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951351Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951368Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951375Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951399Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951405Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951412Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952075Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952082Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954826Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954833Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954840Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954857Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954864Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954871Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954888Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954895Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
00607411919077Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919091Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919121Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26