Medegen Medical Products, LLC

Basic Information

• Brand Name: Medegen Medical Products, LLC
• Primary DI: 00700812002192
• Version / Model: PC8827-500
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• 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: 444e96f8-9bb4-48ab-8375-4bf7a291226d

Device Description

Spec Cont 4.5oz wo/Lbl Bulk 500/cs 28/pl

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
NNI	CONTAINER, SPECIMEN, NON-STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31400	Sterile urine specimen container IVD	A sterile covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00700812002192	GS1
Unit of Use	10700812002199	GS1