FDA.reportPublic FDA data

AirLife™

Primary DI
10190752114449
Brand
AirLife™
Company
AIRLIFE
Model
2K8037C2
Catalog number
2K8037C2
Device description
Pediatric Manual Resuscitator
Published
2021-05-03
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
OEVCardiopulmonary resuscitation aid kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752114447PackageGS16In Commercial Distribution
10190752114449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075211444750190752114447
1019075211444910190752114449

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

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
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
10194717121022Regard™ROI CPS, LLCOEV2025-02-18
10889483166291SuperNO2VAAIRLIFEOEV2025-02-14
10889483166307SuperNO2VAAIRLIFEOEV2025-02-14
10889483606025SuperNO2VAAIRLIFEOEV2025-02-14
10889483606049SuperNO2VAAIRLIFEOEV2025-02-14
10194717121039Regard™ROI CPS, LLCOEV2025-02-13
10194717121046Regard™ROI CPS, LLCOEV2025-02-13
10194717121053Regard™ROI CPS, LLCOEV2025-02-13
10194717121060Regard™ROI CPS, LLCOEV2025-02-13
10194717120971Regard™ROI CPS, LLCOEV2025-02-10
10194717120988Regard™ROI CPS, LLCOEV2025-02-10
10194717120216Regard™ROI CPS, LLCOEV2024-10-31
10194717120223Regard™ROI CPS, LLCOEV2024-10-31
10194717120254Regard™ROI CPS, LLCOEV2024-10-31
10194717120261Regard™ROI CPS, LLCOEV2024-10-31
10194717120278Regard™ROI CPS, LLCOEV2024-10-31
10194717120230Regard™ROI CPS, LLCOEV2024-10-30
10194717120247Regard™ROI CPS, LLCOEV2024-10-30
10194717120285Regard™ROI CPS, LLCOEV2024-10-30
10194717120186Regard™ROI CPS, LLCOEV2024-10-21
10194717120193Regard™ROI CPS, LLCOEV2024-10-21
10194717120209Regard™ROI CPS, LLCOEV2024-10-21
10194717120001Regard™ROI CPS, LLCOEV2024-10-02
10194717120049Regard™ROI CPS, LLCOEV2024-09-27
10194717119883Regard™ROI CPS, LLCOEV2024-08-01
10194717119876Regard™ROI CPS, LLCOEV2024-07-15
10194717119838Regard™ROI CPS, LLCOEV2024-07-05
10194717119845Regard™ROI CPS, LLCOEV2024-07-05
10194717119777Regard™ROI CPS, LLCOEV2024-06-25
10194717119784Regard™ROI CPS, LLCOEV2024-06-25