Duns Number:029578633
Device Description: The 50E is a rechargeable pulse oximeter designed to accurately measure oxygen saturation The 50E is a rechargeable pulse oximeter designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
Catalog Number
-
Brand Name
FaceLake
Version/Model Number
CMS-50E
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
K090671
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
007eec34-04f4-4426-a3e7-2b89097eda29
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
October 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |