Identity
- Trade Name
- Masimo FDA UDI
- Generic Name
- Pulse oximeter probe, reprocessed FDA UDI
- Device Name
- LNCS Pediatric Probe FDA UDI
- Model / Reference
- RM-1860 FDA UDI
- Description
- LNCS Pediatric Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816317023973 FDA UDI
- 510(k) Number
- K081927 FDA UDI
- FDA Product Code
- NLF FDA UDI
- GMDN Term
- Pulse oximeter probe, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter probe, reprocessed
Masimo by Renu Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081927 also covers:
- Masimo — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC
- Pulse Oximeter Probe — RENU MEDICAL, INC
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 14abb235-8691-48cd-9187-cb658ee13b97 34 fields · synced Jun 8, 2026