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 (CADM) The Bag Adaptor CP connect to Syringe Adaptor / Syringe Adaptor Lock and to CADM sets
Catalog Number
-
Brand Name
OnGuard2 Chemfort Bag Adaptor CP
Version/Model Number
412166
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,K210707
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
586cc35d-628c-4779-a203-ffbee9632c9c
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 17, 2021
Package DI Number
37290115921664
Quantity per Package
2
Contains DI Package
27290115921667
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 |