| Device Type ID | 2423 |
| Device Name | Blood Establishment Computer Software And Accessories |
| Regulation Description | Blood Establishment Computer Software And Accessories. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9165 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2423 |
| Device | Blood Establishment Computer Software And Accessories |
| Product Code | MMH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Establishment Computer Software And Accessories. |
| CFR Regulation Number | 864.9165 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOLIFE PLASMA SERVICES LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLOOD BANK COMPUTER SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
CARTER BLOODCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CPSI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DATA INNOVATIONS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEPARTMENT OF VETERANS AFFAIRS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EPIC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EPIC SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GRIFOLS DIAGNOSTIC SOLUTIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HAEMONETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
HAEMONETICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
HEALTHCARE-ID, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
IT SYNERGISTICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL INFORMATION TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIWARE INFORMATION SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SCC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCC SOFT COMPUTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRATEC BIOMEDICAL UK LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SUNQUEST INFORMATION SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Computer Software Problem | 5 |
Application Program Problem | 2 |
Data Problem | 2 |
Programming Issue | 2 |
Incorrect Software Programming Calculations | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Problem With Software Installation | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Loss Of Data | 1 |
Device Difficult To Program Or Calibrate | 1 |
Use Of Device Problem | 1 |
Patient Data Problem | 1 |
Application Network Problem | 1 |
Insufficient Information | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConvaTec, Inc | II | May-16-2018 |