DEVICE: raiing iFertracker (06957324200125)

Device Identifier (DI) Information

raiing iFertracker
WT702
In Commercial Distribution

Raiing Medical Company
06957324200125
GS1

1
421278181 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Thermometric fertility analyser A hand-operated, battery-powered, electronic, instrument used for recording basal body temperature and cycle length to identify the fertile and infertile phases of the menstrual cycle. The device consists of a basal body temperature thermometer and a microprocessor programmed with a mathematical algorithm to calculate and identify temperature shifts. It is used to predict ovulation to optimize the chances for becoming pregnant or for determining safe periods where sexual intercourse may take place. It is typically a noninvasive, automatic device.
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FDA Product Code

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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
Yes
Sterilization Method [?]
Liquid Chemical
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4b55b297-993b-4336-9e39-5ccc402b7529
March 29, 2018
2
September 27, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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