Identity
- Trade Name
- Chroma 5 Lead Patient Cable FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- 5 lead ECG patient cable to be used with the Chroma device. FDA UDI
- Model / Reference
- 100605 FDA UDI
- Description
- 5 lead ECG patient cable to be used with the Chroma device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856298006220 FDA UDI
- 510(k) Number
- K083382 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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 ambulatory recorder
Chroma 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
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 dbea8215-6b84-4688-b877-b044b7022255 35 fields · synced Jun 1, 2026