ESSEF

GUDID 16931562700644

intended to measure human body temperature

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

Intermittent electronic patient thermometer
Primary Device ID16931562700644
NIH Device Record Keycf544575-cad3-4310-a504-1ca710986d01
Commercial Distribution StatusIn Commercial Distribution
Brand NameESSEF
Version Model NumberT516
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
GS116931562700644 [Primary]

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-11