Identity
- Trade Name
- LIFE-PATCH® ECG Electrodes (3/pack) FDA UDI
- Generic Name
- Multifunction cardiac treatment electrode FDA UDI
- Device Name
- LIFEPATCH ECG ELECT,ADULT 3/PER PAK FDA UDI
- Model / Reference
- 11100 FDA UDI
- Description
- LIFEPATCH ECG ELECT,ADULT 3/PER PAK FDA UDI
Identifiers
- Catalog Number
- 11100-000001 FDA UDI
- Primary DI / UDI-DI
- 00681490587228 FDA UDI
- 510(k) Number
- K091856 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Multifunction cardiac treatment electrode 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multifunction cardiac treatment electrode
LIFE-PATCH® ECG Electrodes (3/pack) by PHYSIO-CONTROL, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI a33fc4a3-c677-46a3-b458-4d9311b71656 36 fields · synced Jun 9, 2026