Duns Number:029578633
Device Description: The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measu The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2.
Catalog Number
-
Brand Name
FaceLake
Version/Model Number
FL-400
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)
Yes
Over the Counter (OTC)
Yes
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
7f9512dc-6b8b-4543-a869-75ea30a5a6dc
Public Version Date
August 16, 2022
Public Version Number
4
DI Record Publish Date
October 25, 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 |