Model: Jewel Mobile App
Catalog: com.elementscience.es-2
DI: 00850047782052
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Jewel Mobile Application (iOS) Version 2.00.000
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d37ae1b5-dd11-4a93-998f-7d24d5d8081b
Distribution Status:
In Commercial Distribution
DUNS Number:
079801768
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850047782052
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 48052
Name: Wearable defibrillation system defibrillator
Definition:
A portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.
FDA Product Codes
MVK
Wearable Automated External Defibrillator
Premarket Submissions
Item #1 - Submission Number:
P230022
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
P230022
Item #2 - Supplement Number:
003