AccessGUDID - DEVICE: seca analytics 115 (04012030013383)

GUDID

Device Identifier (DI) Information

Brand Name: seca analytics 115
Version or Model: 115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1151306010
Company Name: seca GmbH & Co. KG

Primary DI Number: 04012030013383
Issuing Agency: GS1
Commercial Distribution End Date: November 03, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 316584937 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSX	Software, transmission and storage, patient data

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d37b5adb-ce84-4b20-b6cf-f186664475de
Public Version Date: November 04, 2022
Public Version Number: 3
DI Record Publish Date: August 15, 2018