Duns Number:134139174
Device Description: ClearSight Finger Cuff Large
Catalog Number
CSC2L
Brand Name
ClearSight
Version/Model Number
CSC2L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
K190130,K190130
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
148de618-efd3-4ff0-832a-ee3f31b9b540
Public Version Date
July 07, 2021
Public Version Number
2
DI Record Publish Date
December 13, 2019
Package DI Number
50690103199623
Quantity per Package
5
Contains DI Package
00690103199628
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |