Physiologic LuminA Blood Pressure Monitor

Primary DI
00057565968887
Brand
Physiologic LuminA Blood Pressure Monitor
Company
A.M.G. Médicale Inc
Model
106-934
Device description
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 bagMeets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International ProtocolIncludes: 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)
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05756599581448PackageGS112In Commercial Distribution
00057565968887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05756599581448057565995814485756599581448
00057565968887000575659688870575659688870057565968887

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device 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.

Regulatory Flags#

DUNS number
207372814
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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