DEVICE: NA (04715309129425)

Device Identifier (DI) Information

NA
U-TW1
In Commercial Distribution

PANPAC MEDICAL CORPORATION
04715309129425
GS1

1
657528899 *Terms of Use
Mini Ovulation Microscope for Smartphone is to observe the density of fern crystallization from your saliva(NaCI) to determine whether or not has ovulated.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
LHD Device, Fertility Diagnostic, Proceptive
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

577ccf46-80de-49ba-bfa7-c0bbacde0d4a
March 29, 2018
2
August 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+866286472242
service@panpac.com.tw
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