FDA.report

AirLife™

Primary DI
50190752114270
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
2K8013
Catalog number
2K8013
Device description
AirLife™ Pediatric Mouth-to-Mask Resuscitator Oxygen Port, Filter, 6 inch (15 cm) Tubing, Mouthpiece
Published
2020-02-04
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

Related Records

Contact Domains

Product Codes

CodeName
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752114270PackageGS110In Commercial Distribution
10190752114272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075211427050190752114270
1019075211427210190752114272

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags

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

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0503026716154622mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
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10889483587072Vital Signs™AirLife Finland OyOFP2025-04-14
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