Medegen Medical Products, LLC

Basic Information

• Brand Name: Medegen Medical Products, LLC
• Primary DI: 00700812002024
• Version / Model: M4625
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-12-20
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: 3bc5b49e-01c9-4d71-a9d6-c4b5d5455d5e

Device Description

Kit Urine Collection 50/cs 56cs/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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12542	Midstream urine specimen container IVD	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00700812002024	GS1
Unit of Use	10700812002021	GS1