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MasimoSET DC-8 SpO2 Adult Reusable Sensor

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
MasimoSET DC-8 SpO2 Adult Reusable Sensor FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
MasimoSET DC-8 SpO2 Adult Reusable Sensor FDA UDI
Model / Reference
2387 FDA UDI
Description
MasimoSET DC-8 SpO2 Adult Reusable Sensor FDA UDI

Identifiers

Catalog Number
2387 FDA UDI
Primary DI / UDI-DI
00843997004398 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

No

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

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

MasimoSET DC-8 SpO2 Adult Reusable Sensor by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 1ab291ca-09c3-4609-9492-c6e828741bc2 36 fields · synced May 30, 2026