Duns Number:071829634
Device Description: SEGMENTAL CUFF SELECTOR - A pneumatic valve system for interconnecting a cuff inflator to SEGMENTAL CUFF SELECTOR - A pneumatic valve system for interconnecting a cuff inflator to one or multiple blood pressure cuffs. The cuffs can be deflated completely with the valve(s) of the pneumatic valve system, separately from the cuff inflator.
Catalog Number
00387
Brand Name
Hokanson
Version/Model Number
MV10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2017
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K842067
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
293dda24-c087-4b13-8c38-e2da6a532bcf
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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. | 218 |