Identity
- Trade Name
- Ameritus FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- small size ecg electrode FDA UDI
- Model / Reference
- AMG-503-SM FDA UDI
- Description
- small size ecg electrode FDA UDI
Identifiers
- Catalog Number
- AMG-503-SM FDA UDI
- Primary DI / UDI-DI
- 10817522010366 FDA UDI
- 510(k) Number
- K050443 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic lead set, 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
Category: Electrocardiographic lead set, single-use
Ameritus by Kentec Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050443 also covers:
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
- Kentec Medical, Inc.
Sources (1)
- FDA UDI d2c36f78-fb96-45c5-955e-ea1764e8fe3d 36 fields · synced May 30, 2026