Identity
- Trade Name
- KENTEK BLUE SONIC FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- KENTEK BLUE SONIC WET GEL EKG ELECTRODES FDA UDI
- Model / Reference
- KBS22 FDA UDI
- Description
- KENTEK BLUE SONIC WET GEL EKG ELECTRODES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810003754264 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic electrode, single-use
Kentek Blue Sonic by Kentron Health Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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
- Kentron Health Care, Inc.
Sources (1)
- FDA UDI 26fce741-62f0-49ec-92be-1a375af9bc1e 33 fields · synced Jun 1, 2026