Duns Number:600029649
Device Description: TEVADAPTOR® Luer Lock Adaptor for use with OnGuardTM contained Medication System
Catalog Number
MG412114
Brand Name
TEVADAPTOR® Luer Lock Adaptor
Version/Model Number
MG412114
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141448,K141448,K141448
Product Code
ONB
Product Code Name
Closed antineoplastic and hazardous drug reconstitution and transfer system
Public Device Record Key
1ff4fadb-f02f-409f-a9fd-f232131394d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
27298119121144
Quantity per Package
4
Contains DI Package
17298119121147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-