Duns Number:078497467
Device Description: Upper Arm Blood Pressure Monitor* with cuff 8.7 - 16.5 in (22 - 42 cm)
Catalog Number
-
Brand Name
Vitalcontrol
Version/Model Number
SBM47
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
ad757f9e-786b-4438-98a5-54fbfac73aaf
Public Version Date
June 29, 2021
Public Version Number
3
DI Record Publish Date
September 09, 2019
Package DI Number
10850003500321
Quantity per Package
4
Contains DI Package
00850003500324
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 |