Identity
- Trade Name
- Telemetry 5 Lead Patient Cable FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Model / Reference
- Telemetry 5 Lead Patient Cable FDA UDI
Identifiers
- Catalog Number
- 100234 FDA UDI
- Primary DI / UDI-DI
- 00856298006084 FDA UDI
- 510(k) Number
- K050778 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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: Electrocardiograph, professional, multichannel
Telemetry 5 Lead Patient Cable by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050778 also covers:
- Angel — SCOTTCARE CORPORATION, THE
- Innovo — SCOTTCARE CORPORATION, THE
- TeleRehab Computer — SCOTTCARE CORPORATION, THE
- TeleRehab Rack Server — SCOTTCARE CORPORATION, THE
- TeleRehab Receiver Box — SCOTTCARE CORPORATION, THE
- TeleRehab Receiver Card — SCOTTCARE CORPORATION, THE
- TeleRehab Software File Manager — SCOTTCARE CORPORATION, THE
- TeleRehab Software Work Station/Seat License — SCOTTCARE CORPORATION, THE
- Telemetry 3 Lead Patient Cable — SCOTTCARE CORPORATION, THE
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
- Scottcare Corporation, The
Sources (1)
- FDA UDI 7ab23221-8e4d-41da-aa73-853e7b993788 36 fields · synced Jun 8, 2026