FDA.reportPublic FDA data

Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)

Primary DI
00792293793201
Brand
Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)
Company
UROCARE PRODUCTS, INC.
Model
79320
Catalog number
79320
Device description
"BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else?Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defects through each phase of manufacturing and packaged individually in an easy-open Zip-Loc® bag with two(2) “latex-free” leg straps and application instructions.Features/Contains:Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Front with White Back for easy monitoring for blood or other substances in urine, ""Latex-Free"" Leg Straps with Buttons #60062 and Illustrated Application Instructions."
Published
2020-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293793201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293793201007922937932017922937932010792293793201

GMDN Terms#

Term, Definition table
TermDefinition
Wearable urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.5Inch
Height15Inch
Total Volume32Fluid Ounce
Total Volume1000Milliliter
Weight0.14Pound
Width5.25Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293063106"Urocare® Fabric Foley® Catheter/Tubing Strap Standard 18"""631063102018-05-30
00792293063113"Urocare® Fabric Foley® Catheter/Tubing Strap Arm 14"""631163112018-05-30
00792293063120"Urocare® Fabric Foley® Catheter/Tubing Strap Large 22"""631263122018-05-30
00792293063137"Urocare® Fabric Foley® Catheter/Tubing Strap Abdominal 34"""631363132018-05-30
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
00792293043993Urocare® Male Urinal Kit, Laced Closue, Small439943992018-04-11
00792293044006Urocare® Male Urinal Kit, Laced Closue, Medium440044002018-04-11
00792293044013Urocare® Male Urinal Kit, Laced Closue, Large440144012018-04-11
00792293044020Urocare® Male Urinal Kit, Velcro® Closue, Small440244022018-04-11
00792293044037Urocare® Male Urinal Kit, Velcro® Closue, Large440344032018-04-11
00792293044044Urocare® Male Urinal Kit, Laced Closue, Extra-Large440444042018-04-11
00792293044204"Urocare® Male Urinal Suspensory Garment, Laced Closure, Small 26"" to 38"" Waist"442044202018-04-12
00792293044211"Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38"" to 46"" Waist"442144212018-04-12
00792293062000Urocare® Latex-Free Anti-Snoring Strap620062002018-05-29
00792293944023Urocare® Male Urinal System, Velcro® Closue, Small94402944022018-04-11
00792293055002Uro-Prep® Protective Skin Barrier Wipes (Box of 50)550055002018-06-01

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10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05