Duns Number:961027315
Device Description: Medi-Vac Tubing Connector "Y" 3/8 in Polypropylene
Catalog Number
359
Brand Name
CARDINAL HEALTH
Version/Model Number
359
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
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
BYX
Product Code Name
TUBING, PRESSURE AND ACCESSORIES
Public Device Record Key
480d4963-9e87-430d-98f2-cede56b37c82
Public Version Date
April 18, 2019
Public Version Number
3
DI Record Publish Date
November 06, 2018
Package DI Number
50885380015715
Quantity per Package
10
Contains DI Package
20885380015714
Package Discontinue Date
-
Package Status
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 |