Duns Number:062312574
Device Description: Fingertip Pulse Oximeter
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
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
OCH
Product Code Name
Oximeter, Infrared, Sporting, Aviation
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
Package DI Number
10050428402020
Quantity per Package
48
Contains DI Package
00050428402023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping case
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 |