CVS Health - Fingertip Pulse Oximeter - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Duns Number:062312574

Device Description: Fingertip Pulse Oximeter

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More Product Details

Catalog Number

-

Brand Name

CVS Health

Version/Model Number

CVS Health C20

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Device Record Status

Public Device Record Key

0b8f49ad-c514-4c05-b436-bd66db841d98

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

10050428402020

Quantity per Package

48

Contains DI Package

00050428402023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping case

"WOONSOCKET PRESCRIPTION CENTER, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 139
U Unclassified 23