Duns Number:303562672
Device Description: SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide09120073930118,
Catalog Number
21-FHCN-15525
Brand Name
CNAP® Monitor 500
Version/Model Number
V1.5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 2018
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082599
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
3195c36d-cc80-4920-b948-0650c1b31b9d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 29, 2017
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. | 71 |