ViveCare

Basic Information

• Brand Name: ViveCare
• Primary DI: 00810178882458
• Version / Model: LVA3075FLG30
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-04
• Public Version: 1
• Public Version Date: 2025-04-14
• Public Version Status: New
• Public Device Record Key: 6552b85d-cbd4-45a2-898e-4c78af70ec6f

Device Description

Breast Pump Accessory (30mm Flange)

Device Characteristics

• Single Use: No
• 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: No
• 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
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12463	Breast pump support kit, single-use	A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and milk collection containers (e.g., bottle, cup). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810178882455	GS1	Case	100	In Commercial Distribution
Primary	00810178882458	GS1

Premarket Submissions

Submission Number	Supplement Number
K191802	000