Duns Number:007941230
Device Description: Cuff Blood Pressure Bladder Inflation System Nylon Reusable 2-Tube With Bulb And Valve Adu Cuff Blood Pressure Bladder Inflation System Nylon Reusable 2-Tube With Bulb And Valve Adult Long Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
M3403L
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
1576faa2-d6fc-4daf-a5db-89b55e6e0665
Public Version Date
October 19, 2020
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632115538
Quantity per Package
5
Contains DI Package
10885632115530
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 |