Duns Number:533172743
Device Description: Luer Lock Adaptor Swivel
Catalog Number
LL-2S
Brand Name
Equashield
Version/Model Number
Luer Lock Adaptor Swivel
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
418e900e-5931-4961-9886-82280519d92a
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 2022
Package DI Number
17290013484656
Quantity per Package
120
Contains DI Package
07290013484659
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |