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
Rx
false
OTC
true
Sterile
false
Single use
false

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, reusableA portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient and is not intended to measure urine output. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Total Volume0
Weight0
Width0

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293041005Urocare® Reusable Urinary Drainage Bottle 2,000 mL.410041002018-04-11
00792293041012Urocare® Cap with Housing for Reusable Urinary Drainage Bottle410141012018-04-11
00792293041029Urocare® Hooks for Reusable Urinary Drainage Bottle410241022018-04-11
00792293060013Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)600160012018-04-11
00792293060037Urocare® Top Adapter for Urinary Drainage Bottle600360032018-04-11
00792293060167Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
00792293060174Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31
00792293060181Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18"601860182018-05-31
00792293060198Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18"601960192018-05-31
00792293060617Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606160612018-04-11
00792293060860Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18"608660862018-05-31
00792293069993Urocare® Thumb Tube Clamp, Adjustable699969992018-04-11
00792293070005Urocare® Thumb Tube Clamp, Two-Position700070002018-04-11
00792293070036Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm)700370032018-06-01
00792293702043Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)7002047002042018-06-01
00792293702166Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)7002167002162018-06-01
00792293060006Urocare® Gasket Ring, Large (Set of 10)600060002018-04-11
00792293060204Urocare® Tubing Clear-Vinyl with Connector and Sterile 0.31" x 18"602060202018-05-31
00792293060600Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606060602018-04-11
00792293060853Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5"608560852018-05-31

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