NNZClass I

System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile

21 CFR 876.5250 / Gastroenterology, Urology

NNZ is the FDA product code for System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile, a class I device type, regulated under 21 CFR 876.5250. FDA's definition for this code reads: "Urine collector and accessories; see product code EYZ". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NNZ
Device name: System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
FDA definition: Urine collector and accessories; see product code EYZ.
Regulation: 21 CFR 876.5250
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order

Recent clearances

Product code NNZ

FDA records hold no clearances under product code NNZ.

Recent recalls

Product code NNZ

Z-2553-2015Class IIRecall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products...Customed, Inc / initiated 2015-07-10 / 960 trays

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)