AccessGUDID - DEVICE: NA (04715309129425)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: U-TW1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309129425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61073	Personal ovulation microscope IVD	A non-sterile, hand-held eyepiece with a magnifying lens intended to be used for the visualization of crystallised patterns in a female’s saliva sample, which may identify the days of ovulation i.e., the most fertile days in the menstrual cycle, as an aid for natural conception. It is available [non-prescription] over-the-counter (OTC) for home-use and is not intended to be used as a form of contraception. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHD	Device, Fertility Diagnostic, Proceptive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between -15 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 577ccf46-80de-49ba-bfa7-c0bbacde0d4a
Public Version Date: June 25, 2020
Public Version Number: 3
DI Record Publish Date: August 18, 2016