FDA.reportPublic FDA data

AirLife™

Primary DI
30889483570887
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001955
Catalog number
001955
Device description
AirLife™ Tempo2-II™ Thermometer Unit Two 22 mm OD Adapters
Published
2025-03-27
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

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
30889483570887PackageGS150In Commercial Distribution
10889483570883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357088730889483570887
1088948357088310889483570883

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119058668
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27
30889483573383AirLife™1209-5031209-5032025-03-27

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
10889483570876AirLife™AIRLIFEFQZ2025-03-06
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