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MasimoSET® ReSposable™ DB9 S-ROS 12U SpO2 Reusable Optical Sensor (ROS)

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
MasimoSET® ReSposable™ DB9 S-ROS 12U SpO2 Reusable Optical Sensor (ROS) FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Model / Reference
2621 FDA UDI

Identifiers

Primary DI / UDI-DI
00843997006903 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® ReSposable™ DB9 S-ROS 12U SpO2 Reusable Optical Sensor (ROS) by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID

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 39f47218-a0f4-46e4-a4b6-33a38b48a67f 33 fields · synced Jun 1, 2026