Duns Number:071829634
Device Description: ARTERIAL INFLOW SYSTEM - Measures arterial inflow in the extremities using the principle o ARTERIAL INFLOW SYSTEM - Measures arterial inflow in the extremities using the principle of venous occlusion plethysmography. The system uses software to combine strain gauge plethysmography, rapid cuff inflation, and optional R-wave heart beat detection and invasive blood pressure to measure the arterial inflow rate in one or two limbs simultaneously.
Catalog Number
00576
Brand Name
Hokanson
Version/Model Number
AI6
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K023707
Product Code
JOM
Product Code Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Public Device Record Key
21d7c461-dd14-4581-a70a-62afd2cfcc4d
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
December 12, 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. | 218 |