Definition: Urine Collector And Accessories; See Product Code EYZ.
Device Type ID | 2036 |
Device Name | System, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile |
Regulation Description | Urine Collector 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) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 876.5250 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NNZ |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2036 |
Device | System, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile |
Product Code | NNZ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Urine Collector And Accessories. |
CFR Regulation Number | 876.5250 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Customed, Inc | II | Sep-03-2015 |