AccessGUDID - DEVICE: Embrace2 (08538580061330)

GUDID

Device Identifier (DI) Information

Brand Name: Embrace2
Version or Model: Embrace
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EM2-FP-S
Company Name: EMPATICA SRL

Primary DI Number: 08538580061330
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 430141750 *Terms of Use

Device Description: No description.

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):	Yes
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?
61288	Home seizure monitoring system	An assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POS	Physiological Signal Based Seizure Monitoring System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: aeb0064f-5462-4b85-a5b6-cc3bec05e437
Public Version Date: February 12, 2020
Public Version Number: 2
DI Record Publish Date: November 09, 2018