Jewel Starter Kit JWL1-STRT-K-01

GUDID 00850047782038

ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)

Element Science, Inc.

Wearable defibrillation system defibrillator

• Primary Device ID: 00850047782038
• NIH Device Record Key: 304ceb50-6792-4535-b0be-207b295c0803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jewel Starter Kit
• Version Model Number: ES-2
• Catalog Number: JWL1-STRT-K-01
• Company DUNS: 079801768
• Company Name: Element Science, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047782038 [Primary]

FDA Product Code

• MVK: Wearable Automated External Defibrillator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-20
• Device Publish Date: 2025-05-12

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 Kit: 2025-05-20ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)
• 00850047782038 - Jewel Starter Kit: 2025-05-20 ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)
• 00850047782090 - Jewel Patch: 2025-05-20 Adhesive Electrode Patch (ES-2) (900-00031)