Vive Breathe

GUDID 00810178884049

Compressor Nebulizer with Disposable Kit

VIVE HEALTH LLC

Therapeutic agent nebulizer, ambulatory

• Primary Device ID: 00810178884049
• NIH Device Record Key: 3ca7a639-9991-4a24-bb8a-ae8743bab2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Breathe
• Version Model Number: LVA3109WHT
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810178884049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161586

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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 [Vive Breathe]

• 00810178882977: Compressor Nebulizer Accessories (Pediatric Mask, Disposable)
• 10810178882967: Compressor Nebulizer Accessories (Adult Mask, Disposable)
• 00810178882953: Compressor Nebulizer Accessories (Pediatric Mask, Resuable)
• 00810178882946: Compressor Nebulizer Accessories (Adult Mask, Resuable)
• 00810178881345: Compressor Nebulizer Accessories (Kit, Disposable)
• 00810178881338: Compressor Nebulizer Accessories (Kit, Resuable)
• 10810178881328: Compressor Nebulizer Accessories (Filters 5PK)
• 00810178886814: Compressor Nebulizer Accessories (Tubing)
• 00810178884681: Compressor Nebulizer Accessories (Kit, Disposable) with T Piece
• 00810178884049: Compressor Nebulizer with Disposable Kit
• 00810178886371: Pediatric Compressor Nebulizer Honey The Bear