RD SpO2 - RD SpO2 Patient Cable & Pediatric DCI Sensor - MASIMO CORPORATION

Duns Number:780421038

Device Description: RD SpO2 Patient Cable & Pediatric DCI Sensor

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More Product Details

Catalog Number

-

Brand Name

RD SpO2

Version/Model Number

4871

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

b8815a36-3761-4159-801a-27d2a5331a71

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MASIMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 479