ViveBreathe

GUDID 10810178884459

Portable Oxygen Concentrator (8 Cell Battery)

VIVE HEALTH LLC

Mobile/portable oxygen concentrator

• Primary Device ID: 10810178884459
• NIH Device Record Key: ab54c861-a0d4-4db8-8986-33b1d99db498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViveBreathe
• Version Model Number: LVA3111WHT8
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810178884452 [Primary]
GS1	10810178884459 [Package]; Contains: 00810178884452; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251130

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [ViveBreathe]

• 00810178885190: Portable Oxygen Concentrator Juniper
• 00810178884469: Portable Oxygen Concentrator (16 Cell Battery)
• 10810178884459: Portable Oxygen Concentrator (8 Cell Battery)