AccessGUDID - DEVICE: Urocare® Leg Bag Holder, Upper Large (00792293063847)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Leg Bag Holder, Upper Large
Version or Model: 6384
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6384
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293063847
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGE A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals.

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?
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
FAQ	Bag, Urine Collection, Leg, For External Use, 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
Device Size Text, specify: Can hold up to a 26 fl. oz. (800 mL.) leg bag
Device Size Text, specify: Upper Thigh: 24" DIA. (61cm Ø) Lower Thigh: 19.25" DIA. (49cm Ø)
Weight: 0.20 Pound

Device Record Status

Public Device Record Key: 98410a9b-ed88-421b-9344-5f4181b06f2d
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 29, 2018