Replacement Finger Probes - MASIMO 8 PIN REPLACEMENT FINGER PROBE - PROACTIVE MEDICAL PRODUCTS, LLC

Duns Number:078582655

Device Description: MASIMO 8 PIN REPLACEMENT FINGER PROBE

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More Product Details

Catalog Number

20260

Brand Name

Replacement Finger Probes

Version/Model Number

20260

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

416d6b7e-555a-4c2b-a792-2e7ab1544a8d

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

August 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROACTIVE MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 126