Duns Number:537208717
Device Description: The ri-medic NIBP device is designed for the measurement and display of systolic and diast The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
Catalog Number
1785
Brand Name
ri-medic, Bluetooth®, wall mount, adult cuff and adult cuff obese, latex free
Version/Model Number
1785
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
K070750
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
5bdd5e1d-1f14-4375-91f8-a16a8e576d6d
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 |