Duns Number:141588017
Device Description: ADD-Vantage ADDaptor Connector, Non-DEHP
Catalog Number
1141001
Brand Name
ADD-Vantage
Version/Model Number
1141001
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
K133602,K133602
Product Code
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
a53690bf-18b8-4d95-bfa8-cd727e2eabf4
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
30887787001670
Quantity per Package
25
Contains DI Package
10887787001676
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |