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 ID04012030013352
NIH Device Record Key67b97a23-f2fa-4e9a-838e-779678cdcc0a
Commercial Distribution StatusIn Commercial Distribution
Brand Nameseca 514
Version Model Number514
Catalog Number5141321139
Company DUNS316584937
Company Nameseca GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)5427322
Emailinfo.us@seca.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104012030013352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNWAnalyzer, Body Composition

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number10
Public Version Date2020-02-21
Device Publish Date2016-09-15

On-Brand Devices [seca 514]

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

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