FDA.reportPublic FDA data

AirLife™

Primary DI
10889483570876
Brand
AirLife™
Company
AIRLIFE
Model
001952
Catalog number
001952
Device description
AirLife™ Tempo2-I™ Thermometer with Straight Adapter
Published
2025-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQZThermometer, Clinical Color Change

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQZThermometer, Clinical Color ChangeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483570870PackageGS150In Commercial Distribution
10889483570876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357087030889483570870
1088948357087610889483570876

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00016944401360 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
00016944401377 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
10016944401107 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
00016944401490 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
00016944401506 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
00016944701514TraxItMEDICAL INDICATORS INCFQZ2025-05-08
10016944401480 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
10016944701085TraxItMEDICAL INDICATORS INCFQZ2025-05-08
10889483570869AirLife™AIRLIFEFQZ2025-03-27
10889483570883AirLife™AIRLIFEFQZ2025-03-27
30889483570863AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
30889483570887AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
30889483570870AirLife™Sunmed Group Holdings, LLCFQZ2025-03-06
60016944401447 NexTempMEDICAL INDICATORS INCFQZ2025-02-13
20016944401463 NexTempMEDICAL INDICATORS INCFQZ2025-02-13
00016944401438 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00016944401452 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00016944401476 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
20016944401432 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
10016944401435 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00860447001738TitronicsTITRONICS RESEARCH & DEVELOPMENT COMPANYFQZ2024-01-18
20016944401425NexTempMEDICAL INDICATORS INCFQZ2023-11-17
10016944401176NexTempMEDICAL INDICATORS INCFQZ2023-11-17
10190752157637AirLife™VYAIRE MEDICAL, INC.FQZ2022-08-22
50190752157635AirLife™VYAIRE MEDICAL, INC.FQZ2022-08-22
00016944401346NexTempMEDICAL INDICATORS INCFQZ2021-08-30
00016944401322NexTempMEDICAL INDICATORS INCFQZ2021-08-12
00016944401339NexTempMEDICAL INDICATORS INCFQZ2021-08-12
10016944401114NexTempMEDICAL INDICATORS INCFQZ2021-08-12
20016944401043NexTempMEDICAL INDICATORS INCFQZ2021-05-29