DEVICE: Physiologic essentiA Blood Pressure Monitor (05756596310301)

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Device Identifier (DI) Information

Physiologic essentiA Blood Pressure Monitor
106-930

A.M.G. Médicale Inc
05756596310301
GS1
1
Large easy to read screen • Multi-user (4 x 30 memories) • Heart rate indicator • Date and time indicator • Large cuff size is available (#106-931) Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor and medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference Requires 4 AA batteries (not included)
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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
Automatic-inflation electronic sphygmomanometer, non-portable A mains electricity (AC-powered) electronic device, typically digital, designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.
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FDA Product Code

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Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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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 Status

In Commercial Distribution
September 26, 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
05756599154004 12 05756596310301 In Commercial Distribution Case
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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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None
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Production Identifier(s) in UDI

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Yes
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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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