Identity
- Trade Name
- Ambu WhiteSensor 4841PECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Ambu White Sensor 4841P Electrodewith Bio-Tack sticky gel and foam backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton FDA UDI
- Model / Reference
- 4841P FDA UDI
- Description
- Ambu White Sensor 4841P Electrodewith Bio-Tack sticky gel and foam backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton FDA UDI
Identifiers
- Catalog Number
- 4841P FDA UDI
- Primary DI / UDI-DI
- 05707480129782 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
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Ambu WhiteSensor 4841PECG Electrodes by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ambu A/S
Sources (1)
- FDA UDI 86593cfb-fea5-417e-bb8b-af668c6e392a 37 fields · synced May 31, 2026