Home GUDID 00792293503350 Uro-Con® "High-Quality" Latex Sheaths, Large 35mm (Box of 100)
Primary DI 00792293503350
Brand Uro-Con® "High-Quality" Latex Sheaths, Large 35mm (Box of 100)
Company UROCARE PRODUCTS, INC.
Model 500335
Catalog number 500335
Device description SHEATH, MALE, EXTERNAL, CATHETER, LATEX, HIGH-QUALITY, DISPOSABLE, LARGE 35MM BOX of 100 These latex sheaths are used in conjunction with Uro-Con® Catheter Inserts and pliable white-rubber tubing to construct Uro-Con® “Texas-Style” male external catheters
Published 2018-05-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name NNX Device, Incontinence, Urosheath Type, Non-Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NNX Device, Incontinence, Urosheath Type, Non-Sterile Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00792293503350 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00792293503350 00792293503350 792293503350 0792293503350
GMDN Terms# Term, Definition table Term Definition Urinary incontinence penis sheath/port, single-use, non-sterile A non-sterile device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Outer Diameter 35 Millimeter Weight 0.46 Pound
Regulatory Flags# DUNS number 070637129 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00792293301246 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm 530124 530124 2025-01-01 00792293301284 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm 530128 530128 2025-01-01 00792293301314 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm 530131 530131 2025-01-01 00792293301352 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm 530135 530135 2025-01-01 00792293301406 Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm 530140 530140 2025-01-01 00792293781802 Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) 78180 78180 2020-07-30 00792293781819 Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) 78181 78181 2020-07-30 00792293783202 Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) 78320 78320 2020-07-30 00792293783219 Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) 78321 78321 2020-07-30 00792293791801 Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) 79180 79180 2020-07-30 00792293791818 Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) 79181 79181 2020-07-30 00792293793201 Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) 79320 79320 2020-07-30 00792293793218 Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) 79321 79321 2020-07-30 10792293042009 Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.) 4200 4200 2018-04-10 10792293060096 Urocare® Tubing Connector, Small 0.31" OD x 2.25" 6009 6009 2018-06-01 10792293060102 Urocare® Tubing Connector, Large 0.38" OD x 2.25" 6010 6010 2018-06-01 10792293060133 Urocare® Catheter Connector, Small 0.31" OD x 3" 6013 6013 2018-05-31 10792293060140 Urocare® Catheter Connector, Large 0.38" OD x 3" 6014 6014 2018-05-31 10792293060164 Urocare® Tubing White-Rubber with Connector 0.31" ID x 18" 6016 6016 2018-05-31 10792293060171 Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18" 6017 6017 2018-05-31
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00792293301246 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm UROCARE PRODUCTS, INC. NNX 2025-01-01 00792293301284 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm UROCARE PRODUCTS, INC. NNX 2025-01-01 00792293301314 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm UROCARE PRODUCTS, INC. NNX 2025-01-01 00792293301352 Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm UROCARE PRODUCTS, INC. NNX 2025-01-01 00792293301406 Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm UROCARE PRODUCTS, INC. NNX 2025-01-01 00762123001660 Conveen Security+ Coloplast A/S NNX 2022-12-06 00762123001677 Conveen Security+ Coloplast A/S NNX 2022-12-06 00762123001684 Conveen Security+ Coloplast A/S NNX 2022-12-06 00762123017876 Conveen Security+ Coloplast A/S NNX 2022-12-06 05708932283304 Freedom Clear Advantage Coloplast A/S NNX 2022-12-06 05708932283267 Freedom Clear Advantage Coloplast A/S NNX 2022-12-06 05708932283342 Freedom Clear Advantage Coloplast A/S NNX 2022-12-06 05708932283380 Freedom Clear Advantage Coloplast A/S NNX 2022-12-06 05708932283410 Freedom Clear Advantage Coloplast A/S NNX 2022-12-06 05708932282246 Freedom Clear Coloplast A/S NNX 2022-12-06 05708932282017 Freedom Clear Coloplast A/S NNX 2022-12-06 05708932282215 Freedom Clear Coloplast A/S NNX 2022-12-06 05708932282116 Freedom Clear Coloplast A/S NNX 2022-12-06 05708932282260 Freedom Clear Coloplast A/S NNX 2022-12-06 05708932535939 Conveen Optima Coloplast A/S NNX 2022-12-06 05708932851299 Conveen Optima Coloplast A/S NNX 2022-12-06 05708932535953 Conveen Optima Coloplast A/S NNX 2022-12-06 05708932535984 Conveen Optima Coloplast A/S NNX 2022-12-06 00762123052433 Conveen Optima Coloplast A/S NNX 2022-12-06 05708932285292 Freedom Active Cath Coloplast A/S NNX 2022-12-06 05708932285124 Freedom Active Cath Coloplast A/S NNX 2022-12-06 05708932283489 Freedom Active Cath Coloplast A/S NNX 2022-12-06 05708932299503 Freedom Active Cath Coloplast A/S NNX 2022-12-06 05708932285186 Freedom Cath Coloplast A/S NNX 2022-12-06 05708932285063 Freedom Cath Coloplast A/S NNX 2022-12-06