Duns Number:009831413
Device Description: Pro Advantage Cuff Bladder 2 Tube Adult Black Latex Free
Catalog Number
P549220
Brand Name
Pro Advantage
Version/Model Number
P549220
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
24b17f71-7c98-4a67-b321-6bec7cb2f10c
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
M220P5492205
Quantity per Package
15
Contains DI Package
M220P5492203
Package Discontinue Date
-
Package Status
-
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |