System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
The non-sterile closed urine drainage system for non-indwelling catheters is a urological device used in conjunction with external urinary catheters to collect and contain urine in a closed, hygienic drainage system. It is classified as FDA Class 1 under regulation 876.5250 in the Gastroenterology and Urology specialty, and it is GMP exempt. Product code NNZ does not require 510(k) clearance and is associated with product code EYZ.
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Basic Information
- Product Code
- NNZ
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Urine collector and accessories; see product code EYZ.
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.