Duns Number:521161349
Device Description: for use with OnGuard CSTD containing Tevadaptor Drug Reconstitution and Administration Com for use with OnGuard CSTD containing Tevadaptor Drug Reconstitution and Administration Components
Catalog Number
-
Brand Name
Tevadaptor Syringe Adaptor Lock
Version/Model Number
412126
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
K170680,K170680,K170680
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
0ca8169e-b52e-45d5-aac4-1eb882688c6b
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
Package DI Number
37290115921268
Quantity per Package
6
Contains DI Package
27290115921261
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 |