Jewel Patch JWL1-PTCH-K-01

GUDID 00850047782090

Adhesive Electrode Patch (ES-2) (900-00031)

Element Science, Inc.

Wearable defibrillation system defibrillator
Primary Device ID00850047782090
NIH Device Record Key2daea042-28fc-43b2-b5b3-ac4b9262df24
Commercial Distribution StatusIn Commercial Distribution
Brand NameJewel Patch
Version Model NumberES-2
Catalog NumberJWL1-PTCH-K-01
Company DUNS079801768
Company NameElement Science, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850047782090 [Primary]

FDA Product Code

MVKWearable Automated External Defibrillator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

Devices Manufactured by Element Science, Inc.

00850047782007 - Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel")2025-05-20 ES-2 Reusable Defibrillator Unit, Packaged (900-00032)
00850047782038 - Jewel Starter Kit2025-05-20 ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)
00850047782090 - Jewel Patch2025-05-20Adhesive Electrode Patch (ES-2) (900-00031)
00850047782090 - Jewel Patch2025-05-20 Adhesive Electrode Patch (ES-2) (900-00031)

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