Duns Number:533172743
Catalog Number
-
Brand Name
Equashield
Version/Model Number
Equashield Female Luer Lock Connector 180
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
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
d3e3489e-3d04-4758-bef2-a4d3b0a503f8
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
17290013484564
Quantity per Package
120
Contains DI Package
07290013484567
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |