Duns Number:521161349
Device Description: For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administ For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Y Inline Set connects to Bag Adaptor CP and to a primary set
Catalog Number
-
Brand Name
OnGuard2 Chemfort Closed Y Inline Set
Version/Model Number
412167
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
K210707,K210707
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
7ef3294c-41af-4b42-a169-25f8dc13ebd8
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |