Identity
- Trade Name
- Jewel Starter Kit FDA UDI
- Generic Name
- Wearable defibrillation system defibrillator FDA UDI
- Device Name
- ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036) FDA UDI
- Model / Reference
- ES-2 FDA UDI
- Description
- ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036) FDA UDI
Identifiers
- Catalog Number
- JWL1-STRT-K-01 FDA UDI
- Primary DI / UDI-DI
- 00850047782038 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 Starter Kit by Element Science, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 304ceb50-6792-4535-b0be-207b295c0803 34 fields · synced Jun 8, 2026