FDA.report

AirLife™

Primary DI
50190752116328
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
001203
Catalog number
001203
Device description
AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style, 3 in 1 Mask with Safety Vent, with 7 feet (2.1 m) Crush Resistant Oxygen Tubing
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
KGBMASK, OXYGEN, NON-REBREATHING

Product Code Classifications

CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752116328PackageGS150In Commercial Distribution
10190752116320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075211632850190752116328
1019075211632010190752116320

GMDN Terms

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.

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
false
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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