seca analytics 115

Basic Information

• Brand Name: seca analytics 115
• Primary DI: 04012030013383
• Version / Model: 115
• Catalog Number: 1151306010
• Company Name: seca GmbH & Co. KG
• Labeler DUNS: 316584937
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-15
• Public Version: 3
• Public Version Date: 2022-11-04
• Public Version Status: Update
• Public Device Record Key: d37b5adb-ce84-4b20-b6cf-f186664475de
• Distribution End Date: 2022-11-03

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSX	Software, transmission and storage, patient data

GMDN Terms

Code	Name	Definition	Implantable	Status
57967	Medical equipment clinical data interfacing software	An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04012030013383	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]