Identity
- Trade Name
- LABSYSTEM™ PRO FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Clip Leadwire Set for CLEARSIGN™ Amplifier FDA UDI
- Model / Reference
- M00420010010 FDA UDI
- Description
- ECG Clip Leadwire Set for CLEARSIGN™ Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729882749 FDA UDI
- FDA Product Code
- DRQ FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2060 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
Labsystem™ Pro by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, 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
- Boston Scientific
Sources (1)
- FDA UDI 3d282e65-ea12-49b2-9103-6a276e63eb34 33 fields · synced Jun 8, 2026