AccessGUDID - DEVICE: Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.) (00792293041401)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)
Version or Model: 4140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4140
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293041401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40504	Hand-held urinal, reusable	A 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. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Depth: 5.50 Inch
Weight: 1.32 Pound
Height: 13.00 Inch
Total Volume: 4000 Milliliter
Width: 7.75 Inch
Total Volume: 128 Fluid Ounce

Device Record Status

Public Device Record Key: 10bdec69-09f1-47ae-bccc-0f7ca1b50b39
Public Version Date: May 10, 2021
Public Version Number: 4
DI Record Publish Date: April 11, 2018