Physiologic essentiA Blood Pressure Monitor

GUDID 05756599154062

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)

A.M.G. Médicale Inc

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 05756599154062
• NIH Device Record Key: 705baf2b-aeb5-4b6c-bc7e-12ffb3b0be4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physiologic essentiA Blood Pressure Monitor
• Version Model Number: 106-930
• 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: true
• 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	00057565069362 [Primary]
GS1	05756596310300 [Primary]
GS1	05756599154062 [Package]; Contains: 05756596310300; Package: Case [12 Units]; In Commercial Distribution
GS1	10057565069369 [Package]; Contains: 00057565069362; Package: Master 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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