Duns Number:134139174
Device Description: CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK
Catalog Number
CSCM
Brand Name
CLEARSIGHT
Version/Model Number
CSCM
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
K140312,K160552,K140312,K160552
Product Code
DSB
Product Code Name
PLETHYSMOGRAPH, IMPEDANCE
Public Device Record Key
5f19105c-071d-49fa-9e23-ebee23617154
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
20690103193354
Quantity per Package
5
Contains DI Package
00690103193350
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 |