AccessGUDID - DEVICE: Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.) (00792293995162)

GUDID

Device Identifier (DI) Information

Brand Name: Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.)
Version or Model: 99516
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99516
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293995162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT LARGE, 16 FL. OZ. (500 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9516, 1 Fabric Sport Bag Strap #6342, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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

FDA Product Code

[?]

Product Code	Product Code Name
MDZ	Cleaners, Medical Devices
FFA	Tube, Drainage, Suprapubic
EXJ	Device, Incontinence, Urosheath Type, Sterile
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile
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
Total Volume: 16 Fluid Ounce
Total Volume: 500 Milliliter
Depth: 10.0 Inch
Height: 6.75 Inch
Width: 6.0 Inch
Weight: 1.78 Pound

Device Record Status

Public Device Record Key: b6e6b7df-1ba6-4f5f-b8b9-b91f81982776
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 09, 2018