RD rainbow SET™ MD20-05 RD rainbow SET Series Patient Cable - MASIMO CORPORATION

Duns Number:780421038

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More Product Details

Catalog Number

-

Brand Name

RD rainbow SET™ MD20-05 RD rainbow SET Series Patient Cable

Version/Model Number

4072

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

8bdcd699-5070-4145-b27b-862296965c94

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

August 25, 2016

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