JASUN

GUDID 06931562702726

intended to measure human body temperature

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.

Infrared patient thermometer, skin
Primary Device ID06931562702726
NIH Device Record Key6276167b-12da-4b43-b499-76323fb74b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameJASUN
Version Model NumberDT-K111J
Company DUNS544611767
Company NameHANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106931562702726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-01
Device Publish Date2025-07-24