| Device Type ID | 2639 |
| Device Name | Dispenser, Liquid Medication |
| Regulation Description | Liquid Medication Dispenser. |
| 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) Exempt |
| CFR Regulation Number | 880.6430 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KYX |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2639 |
| Device | Dispenser, Liquid Medication |
| Product Code | KYX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Liquid Medication Dispenser. |
| CFR Regulation Number | 880.6430 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 12 |
Fluid Leak | 6 |
Cap | 3 |
Packaging Problem | 2 |
Component(s), Broken | 1 |
Device Markings / Labelling Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Unsealed Device Packaging | 1 |
| Total Device Problems | 27 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Corporation Englewood | II | Feb-27-2015 |
| 2 | Baxter Corporation Englewood | II | Dec-24-2014 |