System, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile

Device Code: 2036

Product Code(s): NNZ

Definition: Urine Collector And Accessories; See Product Code EYZ.

Device Classification Information

Device Type ID2036
Device NameSystem, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile
Regulation DescriptionUrine Collector And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNNZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2036
DeviceSystem, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile
Product CodeNNZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUrine Collector And Accessories.
CFR Regulation Number876.5250 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Customed, Inc
II Sep-03-2015
TPLC Last Update: 2019-04-02 20:04:48

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