Identity
- Trade Name
- BlueSensor BRECG Electrodes FDA UDI
- Generic Name
- Neonatal electrocardiographic electrode FDA UDI
- Device Name
- ECG electrodes FDA UDI
- Model / Reference
- BR-80-K/12 FDA UDI
- Description
- ECG electrodes FDA UDI
Identifiers
- Catalog Number
- BR-80-K/12 FDA UDI
- Primary DI / UDI-DI
- 05707480022335 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Neonatal electrocardiographic electrode 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neonatal electrocardiographic electrode
BlueSensor BRECG Electrodes by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medline — MEDLINE INDUSTRIES, 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
- Ambu A/S
Sources (1)
- FDA UDI 4fe1e2c0-4825-406c-8c79-39f973576857 36 fields · synced Jun 8, 2026