Identity
- Trade Name
- MEDLINE RENEWAL FDA UDI
- Generic Name
- Pulse oximeter probe, reprocessed FDA UDI
- Device Name
- SENSOR, LNCS, PEDIATRIC FDA UDI
- Model / Reference
- MAXPR FDA UDI
- Description
- SENSOR, LNCS, PEDIATRIC FDA UDI
Identifiers
- Catalog Number
- MAXPR FDA UDI
- Primary DI / UDI-DI
- 10884389185346 FDA UDI
- 510(k) Number
- K181738 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter probe, reprocessed
Medline Renewal by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, reprocessed.
- Orantech — Orantech Inc. · Class II
- Pulse Oximeter — Rashman Corp. · Class II
- Stryker Sustainability Solutions — Stryker Sustainability Solutions · Class II
- Nellcor Pulse Oximeter Probe — RENU MEDICAL, INC · Class II
- Masimo Pulse Oximeter Probe — RENU MEDICAL, INC · Class II
- Welch Allyn SPO2 Sensor — MEDSOURCE INTERNATIONAL LLC · Class II
- Orantech — Orantech Inc. · Class II
- Pulse Oximeter — Rashman Corp. · Class II
Cleared under the same submission
K181738 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 03905469-fbd9-4667-a5b0-aed567936eca 36 fields · synced Jun 8, 2026