Duns Number:007941230
Device Description: Cuff Blood Pressure Bladder Inflation System Nylon Reusable 2-Tube With Bulb And Valve Sma Cuff Blood Pressure Bladder Inflation System Nylon Reusable 2-Tube With Bulb And Valve Small Adult Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
M3404
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)
-
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
6d53f013-12a0-457b-a1f3-258b60dd134b
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632115545
Quantity per Package
5
Contains DI Package
10885632115547
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |