Identity
- Trade Name
- Philips FDA UDI
- Generic Name
- Electrocardiographic lead set, reprocessed FDA UDI
- Device Name
- ECG Cable, 5-Lead, Grabbers, Single Patient Use, 85cm FDA UDI
- Model / Reference
- RM-989803172031 FDA UDI
- Description
- ECG Cable, 5-Lead, Grabbers, Single Patient Use, 85cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816317024017 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Electrocardiographic lead set, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reprocessed
Philips by Renu Medical, Inc — 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
- Renu Medical, Inc
Sources (1)
- FDA UDI 0bddbba0-2315-41f2-ac96-a39d3b884102 33 fields · synced May 30, 2026