Duns Number:071829634
Device Description: Calculating Cuff Inflator-Wireless Version - A portable cuff inflator with an electronic m Calculating Cuff Inflator-Wireless Version - A portable cuff inflator with an electronic memory and calculator used to measure segmental limb systolic pressures and calculate pressure indices. Inflation and deflation are controlled by the clinician. Measured pressure readings can be stored in memory registers of the device, or sent directly to a computer. The instrument is powered by rechargeable batteries.
Catalog Number
00937
Brand Name
Hokanson
Version/Model Number
TD312RF
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
K842067
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
26cc72ec-fdef-4a89-b293-5c803a88ea61
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
August 31, 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 |