Duns Number:521161349
Device Description: The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to fem The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnGuard2 Syringe Adaptor / Lock connects to the Lusr Lock Adaptor port
Catalog Number
-
Brand Name
OnGuard Luer Lock Adaptor
Version/Model Number
412114
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
K141448,K141448,K141448
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
4a3cb721-00fc-4adb-83da-a1eb91e362b1
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
37290115921145
Quantity per Package
4
Contains DI Package
27290115921148
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. | 11 |