seca 514 5141321139

GUDID 04012030013352

The Medical Body Composition Analyzer seca 514 is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations. The mBCA seca 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages. In healthy individuals aged 18 years and older the BIA function of the device (BIA = Bioelectric Impedance Analysis) allows further parameters such as fatfree mass (FFM) to be estimated automatically. The results are displayed graphically and assist the attending physician with the following medical aspects: • Assessing energy reserves and energy consumption • Determining the fitness level and metabolic activity • Determining fluid status • Obtaining an overview of body composition and comparing to a healthy population The seca 514 is not a diagnostic device. To make an accurate diagnosis, in addition to the results of the seca 514, targeted examinations have to be ordered by the physician and their results taken into account.

seca GmbH & Co. KG

Bioelectrical body composition analyser

• Primary Device ID: 04012030013352
• NIH Device Record Key: 67b97a23-f2fa-4e9a-838e-779678cdcc0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: seca 514
• Version Model Number: 514
• Catalog Number: 5141321139
• Company DUNS: 316584937
• Company Name: seca GmbH & Co. KG
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)5427322
• Email: info.us@seca.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04012030013352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122388

FDA Product Code

• MNW: Analyzer, Body Composition

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 10
• Public Version Date: 2020-02-21
• Device Publish Date: 2016-09-15

On-Brand Devices [seca 514]

• 04012030013369: The Medical Body Composition Analyzer seca 514 is mainly used in hospitals, medical practices an
• 04012030013352: The Medical Body Composition Analyzer seca 514 is mainly used in hospitals, medical practices an