DEVICE: PeriCALM® Tracings™ (B087TRAC03181)

Device Identifier (DI) Information

PeriCALM® Tracings™
03.18.04
In Commercial Distribution

PERIGEN SOLUTIONS LTD
B087TRAC03181
HIBCC

1
533337713 *Terms of Use
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Obstetrical monitoring/analysis software A software program intended to facilitate clinical management of pregnancy and/or labour by providing functionality in one or more of the following areas: data acquisition, recording, analysis, and reporting. It typically processes maternal and/or foetal physiologic parameters [e.g., maternal heart rate (MHR) and foetal heart rate (FHR), maternal oxygen saturation (SpO2) and temperature, intrapartum foetal oxygen saturation (FSpO2), intrauterine/amniotic pressure], and is intended to be used in conjunction with specialized monitors in the maternity unit.
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FDA Product Code

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Product Code Product Code Name
HGM System, Monitoring, Perinatal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980719 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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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

79105f9b-91a6-4bca-abb6-4c4e6f905a4c
July 06, 2018
3
May 30, 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
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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8888665339
support@perigen.com
8663216788
support@perigen.com
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