Vive

Basic Information

• Brand Name: Vive
• Primary DI: 00810113579986
• Version / Model: LVA3080PAK3
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-07
• Public Version: 1
• Public Version Date: 2025-04-15
• Public Version Status: New
• Public Device Record Key: 1ed7074b-0a10-44b7-b076-36976234fd36

Device Description

Urinary Drainage Bag (Leg) 3PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
58917	Non-wearable adult urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from an adult/adolescent patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810113579983	GS1	Case	40	In Commercial Distribution
Primary	00810113579986	GS1