Identity
- Trade Name
- CLARAVUE FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- CLARAVUE PM 5 RT US FDA UDI
- Model / Reference
- 50604-US FDA UDI
- Description
- CLARAVUE PM 5 RT US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700506300174 FDA UDI
- 510(k) Number
- K101685 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
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
MR Unsafe FDA UDI
Category: Electrocardiographic electrode, single-use
Claravue by Nissha Medical Technologies Sas — Class II — FDA UDI — listed in FDA GUDID — 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
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K101685 also covers:
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
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
- Nissha Medical Technologies Sas
Sources (1)
- FDA UDI 3f4047e4-e101-480b-92c5-207884dafe97 36 fields · synced May 30, 2026