FDA.reportPublic FDA data

TempaDOT

Primary DI
00016944301028
Brand
TempaDOT
Company
MEDICAL INDICATORS INC
Model
5122
Catalog number
TD Sterile F
Device description
TempaDOT F Sterile Clinical single use thermometer
Published
2021-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
20016944301022PackageGS12000In Commercial Distribution
00016944301028PrimaryGS10
10016944301025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001694430102220016944301022
00016944301028000169443010280169443010280016944301028
1001694430102510016944301025

GMDN Terms#

Term, Definition table
TermDefinition
Colour-indication patient thermometerA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.00143Pound

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
030104165
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
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
20016944401043NexTemp1116NXT F Regular2021-05-29
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