Device Type ID | 2638 |
Device Name | Container, Liquid Medication, Graduated |
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 | KYW |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2638 |
Device | Container, Liquid Medication, Graduated |
Product Code | KYW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Liquid Medication Dispenser. |
CFR Regulation Number | 880.6430 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Medline Industries Inc | II | Aug-11-2016 |