Definition: To Detect The Presence Of Blood Leaking From An Extracorporeal Connection Or Needle Site In Hemodialysis Patients And Alert The User Or Attending Staff. The Device Detects Colormetric, Chemical, Or Light Modulation Caused By Exposure To Leaking Blood
| Device Type ID | 2076 |
| Device Name | Autonomous Extracorporeal Blood Leak Detector/alarm |
| Physical State | Small Electronic, Microprocessor Assisted "black Box" With A Strap That Is Attached To The Patient's Arm. The Device Has Visual Indicators With Accompanying Audible Alarm |
| Technical Method | An Optical Fiber Is Connected To An Infrared Source At One End And An Infrared Receiver At The Other End. In The Middle Of The Fiber Is A Sharp Bend That Is Covered With An Absorbent Pad. Blood Absorbed Into The Pad Will Cause The Intensity Of Infrar |
| Target Area | Usually The Forearm But Could Be Placed Anywhere A Blood Line And Needle Are Attached To The Body. |
| Regulation Description | Hemodialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2076 |
| Device | Autonomous Extracorporeal Blood Leak Detector/alarm |
| Product Code | ODX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Device Problems | |
|---|---|
Fitting Problem | 1 |
| Total Device Problems | 1 |