Identity
- Trade Name
- MedSource Electrode (4/pk - 150pk/cs ) FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Electrode (4/pk - 150pk/cs ) FDA UDI
- Model / Reference
- MS-65004 FDA UDI
- Description
- Electrode (4/pk - 150pk/cs ) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816703021323 FDA UDI
- 510(k) Number
- K093327 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
- Models / Variants
- 4 FDA UDIpk - 150pk FDA UDIcs 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic electrode, single-use
MedSource Electrode (4 +2 more) by Medsource International Llc — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
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- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K093327 also covers:
- ECG Snap Electrodes — Dynarex Corp.
- MedSource Electrode (10/pk - 60pk/cs) — MEDSOURCE INTERNATIONAL LLC
- MedSource Electrodes — MEDSOURCE INTERNATIONAL LLC
- MedSource Electrodes — MEDSOURCE INTERNATIONAL LLC
- MedSource Electrodes (3/pk - 200pks/cs) — MEDSOURCE INTERNATIONAL LLC
- MedSource Electrodes (30/pk - 20pk/cs) — MEDSOURCE INTERNATIONAL LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medsource International Llc
Sources (1)
- FDA UDI d145c876-4b63-489f-a9d8-33d0e10e739d 34 fields · synced Jun 1, 2026