DEVICE: Doppler Fetal Heart Rate Detector (06937683443128)
Device Identifier (DI) Information
Doppler Fetal Heart Rate Detector
FM-200
In Commercial Distribution
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
FM-200
In Commercial Distribution
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Foetal Doppler system | A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability. |
FDA Product Code
[?]Product Code | Product Code Name |
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KNG | Monitor, Ultrasonic, Fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K100626 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
aa8befc6-5609-4e5f-a5ea-4f2d2f9af544
July 06, 2018
3
October 18, 2016
July 06, 2018
3
October 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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06937683490009 | 1 | 06937683443128 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined