Duns Number:537208717
Device Description: The ri-cardio is a non-invasive oscillometric long-term blood pressure monitor for measuri The ri-cardio is a non-invasive oscillometric long-term blood pressure monitor for measuring systolic and diastolic blood pressure in adult or pediatric patients.
Catalog Number
1760
Brand Name
ri-cardio ABPM (24h BP device) w/cuffs for adults standard and large size
Version/Model Number
1760
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
K003004
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
77f171be-1970-4dff-b126-350ab373f585
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |