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rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor FDA UDI
Generic Name
Pulse Co-oximeter probe, single-use FDA UDI
Device Name
rainbowR20L SpCO SpO2 SpMet Infant Pulse CO-Oximeter® Adhesive Sensor FDA UDI
Model / Reference
2220 FDA UDI
Description
rainbowR20L SpCO SpO2 SpMet Infant Pulse CO-Oximeter® Adhesive Sensor FDA UDI

Identifiers

Catalog Number
2220 FDA UDI
Primary DI / UDI-DI
10843997001455 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse Co-oximeter probe, single-use 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse Co-oximeter probe, single-use

rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulse Co-oximeter probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 4ed60203-1ccc-4bba-a7fe-42ca5bb972b2 36 fields · synced May 31, 2026