Identity
- Trade Name
- Defibrillation Electrodes FDA UDI
- Generic Name
- Electrode conductive skin pad, single-use FDA UDI
- Device Name
- ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC FDA UDI
- Model / Reference
- P-211-M1 FDA UDI
- Description
- ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811331010371 FDA UDI
- FDA Product Code
- DRO FDA UDI
- GMDN Term
- Electrode conductive skin pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5550 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrode conductive skin pad, single-use
Defibrillation Electrodes by Tz Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrode conductive skin pad, single-use.
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- MULTISTIM — COMPASS HEALTH BRANDS CORP. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/ — HEART SYNC INC · Class II
- MULTISTIM — COMPASS HEALTH BRANDS CORP. · 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
- Tz Medical, Inc.
Sources (1)
- FDA UDI 4ddab662-a769-4527-a55b-162491a0c35d 33 fields · synced May 30, 2026