FDA.reportPublic FDA data

Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)

Primary DI
00792293041401
Brand
Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)
Company
UROCARE PRODUCTS, INC.
Model
4140
Catalog number
4140
Device description
"BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, EXTRA-LARGE, REUSABLE, RIGID HDPE, TUBE, 128 FL. OZ. (4,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60"" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999."
Published
2018-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293041401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293041401007922930414017922930414010792293041401

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held urinal, male, reusableA portable, hand-held container intended to be directly urinated into by a male (typically bed-bound) patient for excretory purposes. Some designs may incorporate a handle. It may be available as a bottle with an appropriate opening or as a complete set which includes a funnel, tubing and a collection bottle. It is not intended to be worn by the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth5.5Inch
Height13Inch
Total Volume128Fluid Ounce
Total Volume4000Milliliter
Weight1.32Pound
Width7.75Inch

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
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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