AirLife™

Primary DI
50190752142020
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
3T4691
Catalog number
3T4691
Device description
Basic Tracheostomy Care Kit
Published
2021-04-02
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
CAFNebulizer (direct patient interface)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752142020PackageGS120In Commercial Distribution
10190752142022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075214202050190752142020
1019075214202210190752142022

GMDN Terms

TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. 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
false
HCT/P
false
Kit
true
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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