AccessGUDID - DEVICE: Equate (01943461100492)

GUDID

Device Identifier (DI) Information

Brand Name: Equate
Version or Model: UU-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAL-MART STORES, INC.

Primary DI Number: 01943461100492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: The Universal Urinal is designed to help prevent spills and odor with an attached snap-on lid. Features a sturdy grip for easy handling and can be used in several positions. This urinal is lightweight, durable and easy to clean.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
40955	Hand-held urinal, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNP	Urinal

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
No Device Sizes

Device Record Status

Public Device Record Key: fa840ca2-72d6-4bc6-a9b7-446fdd4cc72f
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 09, 2023