Medegen Medical

Basic Information

• Brand Name: Medegen Medical
• Primary DI: 00700812001201
• Version / Model: H140-01
• Catalog Number: H140-01
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-05-18
• Public Version: 2
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 47fb342b-c278-472e-9fba-228709b73181

Device Description

Urinal wTransCvr 50/cs 24/plt

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNP	Urinal	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10700812001208	GS1
Primary	00700812001201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]