Physiologic LuminA Blood Pressure Monitor

GUDID 05756599581448

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)

A.M.G. Médicale Inc

Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 05756599581448
• NIH Device Record Key: 333281e6-cd65-4fe4-9f00-8454226b2a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physiologic LuminA Blood Pressure Monitor
• Version Model Number: 106-934
• Company DUNS: 207372814
• Company Name: A.M.G. Médicale Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00057565968887 [Primary]
GS1	05756596888748 [Primary]
GS1	05756599581448 [Package]; Contains: 05756596888748; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-26

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