Identity
- Trade Name
- NeoLead FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Pouch of 3 metallic pre-attached leadwire (24.) pediatric/neonatal electrodes. Hydrogel/Hydrocolloid adhesive. AAMI, Standard DIN connector. 1. round. FDA UDI
- Model / Reference
- NeoLead, AAMI metal lead FDA UDI
- Description
- Pouch of 3 metallic pre-attached leadwire (24.) pediatric/neonatal electrodes. Hydrogel/Hydrocolloid adhesive. AAMI, Standard DIN connector. 1. round. FDA UDI
Identifiers
- Catalog Number
- 989803183101 FDA UDI
- Primary DI / UDI-DI
- 20884838035144 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
- 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
No
FDA UDI
Category: Electrocardiographic electrode, single-use
NeoLead by Philips Medical Systems Hsg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Philips Medical Systems Hsg
Sources (1)
- FDA UDI 40c066fd-42ff-4127-a1ba-0c1c419ff34c 36 fields · synced May 30, 2026