Duns Number:521161349
Device Description: The Spike Port Adaptor is part of the OnGuard CSTD system.The devices spike connects to IV The Spike Port Adaptor is part of the OnGuard CSTD system.The devices spike connects to IV solution container.The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug.
Catalog Number
-
Brand Name
OnGuard Spike Port Adaptor
Version/Model Number
412113
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
K141448,K141448
Product Code
ONB
Product Code Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Public Device Record Key
fe6ea7b9-523b-408a-a3eb-5f679893fb1b
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
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 |