seca analytics 115 1151303010

GUDID 04012030013376

The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs

seca GmbH & Co. KG

Medical equipment clinical data interfacing software

• Primary Device ID: 04012030013376
• NIH Device Record Key: fd009a31-f287-4832-b6f2-13cf3a4ab30a
• Commercial Distribution Discontinuation: 2022-11-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: seca analytics 115
• Version Model Number: 115
• Catalog Number: 1151303010
• Company DUNS: 316584937
• Company Name: seca GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04012030013376 [Primary]

FDA Product Code

• NSX: Software, transmission and storage, patient data

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-04
• Device Publish Date: 2018-08-15

On-Brand Devices [seca analytics 115]

• 04012030013406: The seca 115 PC software is for administering weight, height, bioimpedance and vital measurement
• 04012030013383: The seca 115 PC software is for administering weight, height, bioimpedance and vital measurement
• 04012030013376: The seca 115 PC software is for administering weight, height, bioimpedance and vital measurement