N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00810050242202
• Version / Model: 20162
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: d59a0b5b-9616-42e4-80fc-6a638752693e

Device Description

SYSTEM, UROLOGY BAG SUPPORT

Device Characteristics

• Single Use: No
• 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: Yes
• 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
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41052	Non-wearable urine/faecal collection bag holder	A device designed to secure a urine or faecal collection bag (e.g., intestinal ostomy bag), or a respective bag extension, in a stable position and height to an object other than the patient. It is available in a variety of designs (e.g., hanger) and may be intended to attach the bag to objects such as wheelchairs, beds, and chairs occupied by the patient, or it may be a freestanding device with bag-suspending hooks/clips (e.g., portable stand). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050242202	GS1