Medegen Medical Products, LLC

Basic Information

• Brand Name: Medegen Medical Products, LLC
• Primary DI: 00700812001256
• Version / Model: H145-01
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2020-12-20
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: 30410368-43ea-4a3d-b763-e8c10f8dd7ad

Device Description

Urinal Female Transl 36/cs 16/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
37977	Hand-held urinal, female	A portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bed-bound) patient for excretory purposes. The opening for urination will typically be elongated and have slightly raised edges that fit to the female genital anatomy. The device 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 reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00700812001256	GS1
Unit of Use	10700812001253	GS1