Duns Number:521161349
Device Description: Part of the Chemfort OnGuard2 system
Catalog Number
-
Brand Name
ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor
Version/Model Number
412170
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
bc62bb31-a560-4fc5-b33e-ea9f195192f1
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 10, 2021
Package DI Number
37290115921701
Quantity per Package
4
Contains DI Package
27290115921704
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 |