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Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel")
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") FDA UDI
- Generic Name
- Wearable defibrillation system defibrillator FDA UDI
- Device Name
- ES-2 Reusable Defibrillator Unit, Packaged (900-00032) FDA UDI
- Model / Reference
- ES-2 FDA UDI
- Description
- ES-2 Reusable Defibrillator Unit, Packaged (900-00032) FDA UDI
Identifiers
- Catalog Number
- JWL1-MDU0-E-01 FDA UDI
- Primary DI / UDI-DI
- 00850047782007 FDA UDI
- PMA Number
- P230022 FDA UDI
- FDA Product Code
- MVK FDA UDI
- GMDN Term
- Wearable defibrillation system defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Wearable defibrillation system defibrillator
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") by Element Science, Inc. — Class III — FDA UDI — listed in FDA GUDID
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Also classified as Wearable defibrillation system defibrillator.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Element Science, Inc.
Sources (1)
- FDA UDI 776dd86a-db95-4337-a2e6-7a77f5b4ed80 35 fields · synced May 30, 2026