Duns Number:071829634
Device Description: A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volu A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volume changes in a limb or digit. The sensor has a tube filled with electrically resistive fluid (indium-gallium), and is wrapped around the circumference of the limb or digit. The plethysmograph instrument measures the resistance changes of the sensor that occur when the resistive fluid column length changes according to circumference changes that occur with vascular flow changes.
Catalog Number
03355
Brand Name
Hokanson
Version/Model Number
Indium Gallium Strain Gauge
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPT
Product Code Name
Probe, Blood-Flow, Extravascular
Public Device Record Key
6544e536-c53e-406b-b6e0-3ae8078a0f5c
Public Version Date
October 05, 2020
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
00817065021594
Quantity per Package
8
Contains DI Package
00817065021204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 218 |