Identity
- Trade Name
- Cadwell Disposable Patient Starter Kit FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Model / Reference
- 302221-200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067101360 FDA UDI
- 510(k) Number
- K933803 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Inch FDA UDI
Cadwell Disposable Patient Starter Kit by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K933803 also covers:
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell Bar Electrodes — Cadwell Industries, Inc.
- Cadwell Disposable Disc Electrodes — Cadwell Industries, Inc.
- Cadwell Disposable Ground Electrodes — Cadwell Industries, Inc.
- Cadwell Disposable Patient Pak Refill — Cadwell Industries, Inc.
- Cadwell Disposable Ring Electrodes — Cadwell Industries, Inc.
- Cadwell Disposable Tab Electrodes — Cadwell Industries, Inc.
- Cadwell Disposable Tab Electrodes — Cadwell Industries, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI b323968d-c8ae-412d-beaa-f83d50ecda8e 36 fields · synced Jun 9, 2026