FDA.reportPublic FDA data

NexTemp

Primary DI
20016944401043
Brand
NexTemp
Company
MEDICAL INDICATORS INC
Model
1116
Catalog number
NXT F Regular
Device description
NexTemp F Single-use Clinical Thermometer
Published
2021-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
20016944401043PrimaryGS10
10016944401039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2001694440104320016944401043
1001694440103910016944401039

GMDN Terms#

Term, Definition table
TermDefinition
Liquid-crystal patient thermometer, single-useA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.00134Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
030104165
Device count
10000
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016944401360 NexTemp 4500-12NXT Ultra C2025-07-17
00016944401377 NexTemp 4500-24NXT Ultra C2025-07-17
10016944401107 NexTemp 4500-24NXT Ultra C2025-07-17
00016944301028TempaDOT5122TD Sterile F2021-05-29
00016944301035TempaDOT5122NSTD NS F2021-05-29
00016944301080TempaDOT5532TD Sterile C2021-05-29
00016944301134TempaDOT5124NSTD NS F2021-05-29
00016944301141TempaDOT5532NSTD NS C2021-05-29
00016944401100NexTemp8200NXT Ultra C2021-05-29
00016944701088TraxIt2313TXT C2021-05-29
00016944701514TraxIt2313-12TXT C2025-05-08
00016944401490 NexTemp8600-12NXT GO C2025-05-08
00016944401506 NexTemp8600-24NXT GO C2025-05-08
10016944401480 NexTemp8600-24NXT GO C2025-05-08
10016944701085TraxIt2313-12TXT C2025-05-08
00016944301004TempaDOT5001TD AX F2021-05-29
00016944301059TempaDOT5147TD Bulk F2021-05-29
60016944401447 NexTemp8500-25NXT GO F2025-02-13
20016944401463 NexTemp96-8500NXT GO F2025-02-13
00016944401438 NexTemp8500NXT GO F2024-08-29

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
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