FDA.report

AirLife™

Primary DI
50190752145168
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
AH265
Catalog number
AH265
Device description
AirLife™ Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber
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
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752145168PackageGS110In Commercial Distribution
10190752145160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075214516850190752145168
1019075214516010190752145160

GMDN Terms

TermDefinition
Inspiratory line humidification chamber, single-useA non-sterile device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. 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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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