Rexall

GUDID 06931562700623

intended to measure human body temperature in ear canal

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

Infrared patient thermometer, ear
Primary Device ID06931562700623
NIH Device Record Key6474a9ee-e751-4a71-80fd-adeecbfa5e19
Commercial Distribution StatusIn Commercial Distribution
Brand NameRexall
Version Model NumberET-100B
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
GS106931562700623 [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 Date2022-06-27
Device Publish Date2022-06-17