FDA.report

AirLife™

Primary DI
50190752157635
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
001950
Catalog number
001950
Device description
Tempo2-l Thermometer
Published
2022-08-22
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
FQZTHERMOMETER, CLINICAL COLOR CHANGE

Product Code Classifications

CodeDeviceSpecialtyClass
FQZThermometer, Clinical Color ChangeGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752157635PackageGS150In Commercial Distribution
10190752157637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075215763550190752157635
1019075215763710190752157637

GMDN Terms

TermDefinition
Respiratory gas thermometerA non-sterile device intended to measure the temperature of respiratory gases prior to entering a patient’s airway to help manage patient comfort and facilitate therapeutic compliance. It is a slender, hollow glass tube with a bulb at the base that is filled with coloured alcohol whereby temperature is measured based on the capillary principle. It is intended to be inserted into a compatible temperature monitor port of a breathing circuit connecter (e.g., Y-piece connecter); it may be used in the home or healthcare facility. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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