Duns Number:961027315
Device Description: Blood Pressure Cuff, Small Adult 10
Catalog Number
30509-12
Brand Name
CARDINAL HEALTH
Version/Model Number
30509-12
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
Yes
Prescription Use (Rx)
Yes
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
8168b5f7-a3ba-4b35-bfdc-12e2747e53d7
Public Version Date
December 31, 2020
Public Version Number
5
DI Record Publish Date
September 15, 2016
Package DI Number
50885380058200
Quantity per Package
2
Contains DI Package
20885380058209
Package Discontinue Date
December 31, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |