Identity
- Trade Name
- LNCS FDA UDI
- Generic Name
- Pulse Co-oximeter FDA UDI
- Device Name
- Pdtx/Inf/Neo Sensor Kit FDA UDI
- Model / Reference
- 4715 FDA UDI
- Description
- Pdtx/Inf/Neo Sensor Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997015967 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse Co-oximeter 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
Yes
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: Pulse Co-oximeter
Lncs by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse Co-oximeter.
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- Medquip — Drive Devilbiss Healthcare · Class II
- Medquip — Drive Devilbiss Healthcare · Class II
- Radius-7 — MASIMO CORPORATION · Class II
- Radius-7 — MASIMO CORPORATION · Class II
- Radius-PPG — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI e2a0642f-ed87-43d2-8f6a-a5466030f012 35 fields · synced May 30, 2026