Duns Number:078497467
Device Description: SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanomete SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable (with cuff 22-42 cm).
Catalog Number
668.10, 666.16
Brand Name
Vitalcontrol
Version/Model Number
SBM52
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
693a5f87-e752-40a2-890e-d4c592542fa7
Public Version Date
January 28, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2019
Package DI Number
10850003500482
Quantity per Package
4
Contains DI Package
00850003500485
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |