FDA.reportPublic FDA data

NexTemp

Primary DI
10016944401114
Brand
NexTemp
Company
MEDICAL INDICATORS INC
Model
4000-20
Catalog number
NXT Ultra F
Device description
Nextemp Ultra F Disposable Clinical Thermometer, 20Pk (DTC)
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00016944401216PrimaryGS10
00016944401223PrimaryGS10
00016944401247PrimaryGS10
00016944401285PrimaryGS10
00016944401292PrimaryGS10
00016944401308PrimaryGS10
00016944401315PrimaryGS10
00016944401322PrimaryGS10
00016944401339PrimaryGS10
00016944401346PrimaryGS10
10016944401114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016944401216000169444012160169444012160016944401216
00016944401223000169444012230169444012230016944401223
00016944401247000169444012470169444012470016944401247
00016944401285000169444012850169444012850016944401285
00016944401292000169444012920169444012920016944401292
00016944401308000169444013080169444013080016944401308
00016944401315000169444013150169444013150016944401315
00016944401322000169444013220169444013220016944401322
00016944401339000169444013390169444013390016944401339
00016944401346000169444013460169444013460016944401346
1001694440111410016944401114

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
Weight0.0015Pound

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030104165
Device count
20
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
true
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
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
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

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
20016944401043NexTempMEDICAL INDICATORS INCFQZ2021-05-29