Vive Breathe

GUDID 00810178881345

Compressor Nebulizer Accessories (Kit, Disposable)

VIVE HEALTH LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 00810178881345
• NIH Device Record Key: 3f55c10b-bc5e-4e73-b237-06b4099e13f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Breathe
• Version Model Number: LVA3077NKD
• 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	00810178881345 [Primary]
GS1	10810178881342 [Package]; Package: Case [50 Units]; In Commercial Distribution

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: 2025-04-14
• Device Publish Date: 2025-04-04

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)