| Device Type ID | 2642 |
| Device Name | Infusor, Pressure, For I.v. Bags |
| Regulation Description | Pressure Infusor For An I.V. Bag. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5420 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2642 |
| Device | Infusor, Pressure, For I.v. Bags |
| Product Code | KZD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pressure Infusor For An I.V. Bag. |
| CFR Regulation Number | 880.5420 [🔎] |
| Device Problems | |
|---|---|
Air Leak | 105 |
Loss Of Or Failure To Bond | 93 |
Leak / Splash | 15 |
Device Contamination With Chemical Or Other Material | 12 |
Decrease In Pressure | 10 |
Crack | 5 |
Cuff | 5 |
Appropriate Term/Code Not Available | 4 |
Missing Value Reason | 4 |
Device Operates Differently Than Expected | 2 |
Device Operational Issue | 1 |
Infusion Or Flow Problem | 1 |
Inflation Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Bags | 1 |
Break | 1 |
Insufficient Information | 1 |
Pressure Problem | 1 |
Device Issue | 1 |
Misassembly By Users | 1 |
| Total Device Problems | 265 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Jun-26-2017 |