AccessGUDID - DEVICE: Urocare® Gasket Ring, Large (Set of 10) (00792293060006)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Gasket Ring, Large (Set of 10)
Version or Model: 6000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6000
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293060006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10 Replacement Gasket-Ring for: Urinary Drainage Bottle 2,000 mL. #4100, Urinary Drainage Bottle 4,000 mL. #4140 and Anti-Reflux Valve #6001 found in all Urocare Latex Urinary Leg Bags.

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":	No
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?
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, 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.	Obsolete	false
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
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile

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: 0.07 Inch
Weight: 0.01 Pound
Outer Diameter: 0.65 Inch

Device Record Status

Public Device Record Key: c1e2e3b0-70c0-4e95-8423-63236751079f
Public Version Date: May 10, 2021
Public Version Number: 5
DI Record Publish Date: April 11, 2018