FDA.reportPublic FDA data

AirLife™

Primary DI
10190752158474
Brand
AirLife™
Company
AIRLIFE
Model
RES411956B
Catalog number
RES411956B
Device description
Face Tent Mask, 7’O2Tube, O2Stem with Plug
Published
2021-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGLOxygen administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752158472PackageGS150In Commercial Distribution
10190752158474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215847250190752158472
1019075215847410190752158474

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
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
00848530104443Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530104450Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530105402Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108915Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108922Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108908Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-20
00848530108595Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108601Repair LabelSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108526Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108533Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108625Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108762Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108649Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108663Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108687Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108588Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108434Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-18
00848530108311Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-11
00848530108304Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-26
00848530108229REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108243REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108250REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108240REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108257REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19