My Medic

GUDID 00850029189770

A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb ( for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid mano bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transm lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may b on a table, or hand held(portable); blood pressure measurement is taken in conjunction with a stethoscope.

My Medic

Aneroid manual sphygmomanometer

• Primary Device ID: 00850029189770
• NIH Device Record Key: db6e0ffb-e32c-4114-8025-78fd70c09f67
• Commercial Distribution Discontinuation: 2021-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: My Medic
• Version Model Number: Max0203
• Company DUNS: 079772888
• Company Name: My Medic
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850029189770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190902

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-07
• Device Publish Date: 2021-01-16

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