Duns Number:559895730
Device Description: Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spi Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
Catalog Number
19125
Brand Name
XVIVO Click Adapter
Version/Model Number
19125
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"
-
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
NEP
Product Code Name
System/Device, Pharmacy Compounding
Public Device Record Key
41f0e0fb-c712-47cb-b673-e7385a8f30d9
Public Version Date
April 23, 2019
Public Version Number
3
DI Record Publish Date
September 19, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 7 |