DEVICE: Physiologic LuminA Blood Pressure Monitor (05756596888701)

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Device Identifier (DI) Information

Physiologic LuminA Blood Pressure Monitor
106-934

A.M.G. Médicale Inc
05756596888701
GS1
1
This top of the line blood pressure monitor is completely automatic. Once the user is specified, all you have to do is to put on the BP cuff and press the start button. Its large and bright blue screen will insure no straining while reading your systolic, diastolic and pulse results. This blood pressure monitor will also automatically indicate where the user's results are on the 6 level, easy to understand, Hypertension Risk Chart. •Bright easy to read screen •Dual user, 60 memories each •Hypertension Risk Indicator (6 level color classification) •Heart rate indicator / pulse •Date and time indicator •Table top, fully Automatic BP monitor (arm type) •Large screen 2.7 in x 4 in (69 x 102 mm) •Backlight screen when reading is completed •Large, easy to see numbers: 30 mm (Systolic); 20 mm (Diastolic); 9 mm (Pulse) •Inflation/ Deflation icons •Average of Last 3 readings/ results •Irregular Heartbeat detection/ icon •Auto shut off: 3 minutes, if left untouched or forgotten •Low battery indicator insures that users are never without their information/ unable able to take their reading •Carrying bag Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor, medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference, transport bag and instructions. Requires 4 AA batteries (not included) A Large cuff is available (#106-931) (optional) Power adaptor: DC 6V 1000mA AC (#106-933) (not included - optional)
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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
05756599581404 12 05756596888701 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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No CLOSE

Customer Contact

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No Customer Contact currently defined
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