Definition: Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.
| Device Type ID | 2719 |
| Device Name | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Physical State | Vial Adator With Piercing Spikes, Contain Luer-Lock Connector Fitted With Elastomeric Membrane To Provide A Sealed Connection Between Syringe, I.V. Administration Set Or Tranfer Bag. May Contain Side Pressure-equalizing Protector Unit. May Contain Ne |
| Technical Method | Placed Over Vial Or Container Containing The Chemotheraphy Drug |
| Target Area | Device Is Not Act On Any Part Of Body. I.V. Infusion Devices, Catheters, Drug Container Closure System. |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2719 |
| Device | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Product Code | ONB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EQUASHIELD MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ICU MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL SALES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ICU MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JMS NORTH AMERICA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEVA MEDICAL, LTD. (MIGADA PLANT) | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Fluid Leak | 50 |
Connector | 40 |
Leak / Splash | 25 |
Connection Problem | 3 |
Use Of Device Problem | 2 |
Break | 2 |
Device Handling Problem | 1 |
Failure To Deliver | 1 |
Particulates | 1 |
| Total Device Problems | 125 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical, Inc. | I | Feb-22-2019 |
| 2 | ICU Medical, Inc. | II | Oct-11-2018 |
| 3 | J&J Solutions, Inc. DBA Corvida Medical | II | Jan-11-2017 |