Duns Number:867673159
Device Description: Pressure PreventionBlank Product Description: Blood Pressure Unit - Private Label 1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
BPHL
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)
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
05dd887b-6b5d-42c6-af54-2892d7482296
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
July 01, 2016
Package DI Number
50822383537646
Quantity per Package
24
Contains DI Package
00822383537641
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |