AccessGUDID - DEVICE: Medegen Medical Products (00700812001218)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products
Version or Model: H140CR-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H140CR-01
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812001218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: Urinal w/Comfort Ring Att 50/cs 24/plt

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:	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: 0038a0d4-d992-4f05-88ec-539c3c62bac4
Public Version Date: May 10, 2021
Public Version Number: 2
DI Record Publish Date: May 18, 2020