UROCARE PRODUCTS, INC.

Address:2735 MELBOURNE AVE,Pomona,CA,91767,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Collector, Urine, (And Accessories) For Indwelling Catheter (KNX) (5) Device, Incontinence, Urosheath Type, Non-Sterile (NNX) (5) Bag, Urine Collection, Leg, For External Use, Sterile (FAQ) (1)

Premarket Exempt

Yes

Clear

Urocare® Reusable Urinary Drainage Bottle 2,000 mL. - 00792293041005 Catalog Number : 4100

Device Description : BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOK

Device Class : 2

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : KNX

Prescription Use : No

Device Count : 1

Urocare® Cap with Housing for Reusable Urinary Drainage Bottle - 00792293041012 Catalog Number : 4101

Device Description : CAP, BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, REPLACEMENTContai

Device Class : 2

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : KNX

Prescription Use : No

Device Count : 1

Urocare® Hooks for Reusable Urinary Drainage Bottle - 00792293041029 Catalog Number : 4102

Device Description : HOOKS, BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, REPLACEMENTCont

Device Class : 2

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : KNX

Prescription Use : No

Device Count : 1

Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.) - 00792293041401 Catalog Number : 4140

Device Description : BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, EXTRA-LARGE, REUSABLE, RIGID HDP

Device Class : 2

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : KNX

Prescription Use : No

Device Count : 1

Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.) - 00792293042002 Catalog Number : 4200

Device Description : BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VAL

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : KNX, FAQ

Prescription Use : No

Device Count : 1

Urocare® Male Urinal Kit, Laced Closue, Small - 00792293043993 Catalog Number : 4399

Device Description : URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, SMALLContains: 1 M

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : NNX

Prescription Use : No

Device Count : 1

Urocare® Male Urinal Kit, Laced Closue, Medium - 00792293044006 Catalog Number : 4400

Device Description : URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUMContains: 1

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : NNX

Prescription Use : No

Device Count : 1

Urocare® Male Urinal Kit, Laced Closue, Large - 00792293044013 Catalog Number : 4401

Device Description : URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, LARGEContains: 1 M

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : NNX

Prescription Use : No

Device Count : 1

Urocare® Male Urinal Kit, Velcro® Closue, Small - 00792293044020 Catalog Number : 4402

Device Description : URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, SMALLContains: 1

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : NNX

Prescription Use : No

Device Count : 1

Urocare® Male Urinal Kit, Velcro® Closue, Large - 00792293044037 Catalog Number : 4403

Device Description : URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGEContains: 1

Device Class : 1

Duns Number: 070637129

Premarket Exempt : Yes

Product Code : NNX

Prescription Use : No

Device Count : 1

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