FDA.report

AirLife™

Primary DI
50190752145366
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
001503
Catalog number
001503
Device description
AirLife™ Tee Adapter 22 mm O.D. Arms, 18 mm Base Designed for use with Small Nebulizers
Published
2020-01-15
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
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752145366PackageGS150In Commercial Distribution
10190752145368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075214536650190752145366
1019075214536810190752145368

GMDN Terms

TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

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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