GUDID 04715309129425

Mini Ovulation Microscope for Smartphone is to observe the density of fern crystallization from your saliva(NaCI) to determine whether or not has ovul

PANPAC MEDICAL CORPORATION

Personal ovulation microscope IVD
Primary Device ID04715309129425
NIH Device Record Key577ccf46-80de-49ba-bfa7-c0bbacde0d4a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberU-TW1
Company DUNS657528899
Company NamePANPAC MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+866286472242
Emailservice@panpac.com.tw

Operating and Storage Conditions

Storage Environment HumidityBetween -15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104715309129425 [Primary]

FDA Product Code

LHDDevice, Fertility Diagnostic, Proceptive

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 Date2016-08-18

Devices Manufactured by PANPAC MEDICAL CORPORATION

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