FDA.report

Urocare® Male Urinal System, Laced Closue, Medium

Primary DI
00792293944009
Brand
Urocare® Male Urinal System, Laced Closue, Medium
Company
UROCARE PRODUCTS, INC.
Model
94400
Catalog number
94400
Device description
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Small #4420, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
Published
2018-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00792293944009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293944009007922939440097922939440090792293944009

GMDN Terms

TermDefinition
Penis/scrotum wearable urinalA non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter20Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm5301245301242025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm5301285301282025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm5301315301312025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm5301355301352025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm5301405301402025-01-01
00792293781802Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78180781802020-07-30
00792293781819Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78181781812020-07-30
00792293783202Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78320783202020-07-30
00792293783219Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78321783212020-07-30
00792293791801Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79180791802020-07-30
00792293791818Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79181791812020-07-30
00792293793201Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79320793202020-07-30
00792293793218Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79321793212020-07-30
10792293042009Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)420042002018-04-10
10792293060096Urocare® Tubing Connector, Small 0.31" OD x 2.25"600960092018-06-01
10792293060102Urocare® Tubing Connector, Large 0.38" OD x 2.25"601060102018-06-01
10792293060133Urocare® Catheter Connector, Small 0.31" OD x 3"601360132018-05-31
10792293060140Urocare® Catheter Connector, Large 0.38" OD x 3"601460142018-05-31
10792293060164Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
10792293060171Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31

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