← Back to catalogue

Rainbow

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
Rainbow FDA UDI
Generic Name
Pulse Co-oximeter probe, reusable FDA UDI
Device Name
Rainbow DCI-mini SC 1000, 1/Box, Masimo FDA UDI
Model / Reference
3799 FDA UDI
Description
Rainbow DCI-mini SC 1000, 1/Box, Masimo FDA UDI

Identifiers

Catalog Number
3799 FDA UDI
Primary DI / UDI-DI
00843997008990 FDA UDI
510(k) Number
K182887 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse Co-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 Co-oximeter probe, reusable

Rainbow by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse Co-oximeter probe, reusable.

Cleared under the same submission

K182887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 1c791d8e-9eda-4415-acf5-5afcfe140ad3 37 fields · synced May 30, 2026