Meditech

GUDID 05999056500068

The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.

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• Primary Device ID: 05999056500068
• NIH Device Record Key: 3698080a-a2a4-4cc4-815d-c314929ada31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meditech
• Version Model Number: ABPM-06 (BP6)
• Company DUNS: 401235817
• Company Name: MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999056500068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201332

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-03
• Device Publish Date: 2021-11-25

On-Brand Devices [Meditech]

• 05999056500068: The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic
• 05999056500051: The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and d
• 05999056500044: The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and d