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Medical Indicators

United States·US-MF-000018094

Last updated September 18, 2026

About

Disposable thermometers with clinical accuracy, infection control, and ease of use—trusted for better patient care.

From the manufacturer's own website. Source

Information

Country
United States
Address
16, Thomas J Rhodes Industrial Dr, Hamilton, United States
Phone
6095284341
PRRC Contact
Alec Phipps
EUDAMED SRN
US-MF-000018094
FDA FEI Number
—
DUNS Number
—

Catalogue (47)

DeviceModel / ReferenceRegistriesClassStatus
NexTemp 4000-5
FDA UDI
Class IActive
NexTemp 8500-25
FDA UDI
Class IActive
NexTemp 4003-8
FDA UDI
Class IActive
NexTemp 4000-20
FDA UDI
Class IActive
NexTemp 8000
FDA UDI
Class IActive
TempaDOT 5122NS
FDA UDI
Class IActive
NexTemp 4100-12
FDA UDI
Class IActive
NexTemp 4003-4
FDA UDI
Class IActive
NexTemp 4002-8
FDA UDI
Class IActive
NexTemp DTC-04-Custom
FDA UDI
Class IActive
NexTemp 2112US
FDA UDI
Class IActive
NexTemp 95-2402
FDA UDI
Class IActive
NexTemp 8500-12
FDA UDI
Class IActive
TempaDOT 5124NS
FDA UDI
Class IActive
NexTemp 4000-24
FDA UDI
Class IActive
TraxIt 1313
FDA UDI
Class IActive
TempaDOT 5125
FDA UDI
Class IActive
TempaDOT 5122
FDA UDI
Class IActive
NexTemp 4002-4
FDA UDI
Class IActive
NexTemp 8500-24
FDA UDI
Class IActive
NexTemp 1112
FDA UDI
Class IActive
NexTemp 4000-12
FDA UDI
Class IActive
NexTemp 96-8500
FDA UDI
Class IActive
NexTemp 1117
FDA UDI
Class IActive
TempaDOT 5147
FDA UDI
Class IUnknown
TraxIt 4001-12
FDA UDI
Class IActive
NexTemp 8500
FDA UDI
Class IActive
TempaDOT 5001
FDA UDI
Class IUnknown
NexTemp 1116
FDA UDI
Class IUnknown
TempaDOT 5192R
FDA UDI
Class IActive
NexTemp® GO C Bulk Packed 8600-25
EUDAMED
Class IActive
TraxIt Bulk Packed 2313-25
EUDAMED
Class IActive
TempaDOT, C Non-Sterile 5532NS
EUDAMEDFDA UDI
Class IActive
NexTemp Ultra C Stock Promo Pack 4500-24
EUDAMEDFDA UDI
Class IActive
TraxIt C Wearable continuous use 48hrs 2313
EUDAMEDFDA UDI
Class IActive
NexTemp SUT C Ultra Stock Promo Pack 4500-12
EUDAMEDFDA UDI
Class IActive
NexTemp Pro Ultra C Bulked Packed 95-2401
EUDAMED
Class IActive
NexTemp® GO C wrapped 100 CB 8600
EUDAMED
Class IActive
NexTemp® GO C Stock Promo Pack 8600-24
EUDAMEDFDA UDI
Class IActive
NexTemp SUT C Ultra Symbols OW 8200
EUDAMEDFDA UDI
Class IActive
TempaDOT, C Sterile 5532
EUDAMEDFDA UDI
Class IActive
NexTemp SUT C Wrapped 100 CB 2112EU
EUDAMED
Class IActive
TraxIt C Stock Promo Pack 2313-12
EUDAMEDFDA UDI
Class IActive
TempaDOT, C Sterile bulk 5538
EUDAMED
Class IActive
NexTemp® GO C Loose 96-8600
EUDAMED
Class IActive
TempaDOT R 5502R
EUDAMEDFDA UDI
Class IActive
NexTemp® GO C Stock Promo Pack 8600-12
EUDAMEDFDA UDI
Class IActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jul 10, 2013Z-2162-2013—terminated

TempaDot products may have been mislabeled.