Duns Number:004135503
Device Description: Clever Choice Deluxe Pulse Oximeter
Catalog Number
-
Brand Name
Clever Choice
Version/Model Number
SDCMS50DL
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"
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
DQA
Product Code Name
Oximeter
Public Device Record Key
1b4d81f9-635e-4f09-97e7-f1105a303804
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
April 07, 2017
Package DI Number
10898302140183
Quantity per Package
24
Contains DI Package
00898302140186
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 19 |