Duns Number:521161349
Device Description: The product is part of OnGurd2 Chemfort systemFor use with Chemfort OnGuard2 CSTD The dist The product is part of OnGurd2 Chemfort systemFor use with Chemfort OnGuard2 CSTD The distal end of Syringe Adaptor Lock II can connect to a luer syringe or IV set luer lock The proximal end of Syringe Adaptor Lock II can connect to any OnGuard / Chemfort port (Chemfort Vial Adaptor / Chemfort Bag Adaptor SP / Chemfort Luer Lock Adaptor)
Catalog Number
-
Brand Name
OnGuard2 Syringe Adaptor Lock II
Version/Model Number
412174
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
K192866,K192866,K192866
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
34ebe814-2cae-4e4c-82aa-f96bdbbf8be3
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 20, 2022
Package DI Number
37290115921749
Quantity per Package
6
Contains DI Package
27290115921742
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 |