OxyHome

GUDID 00860009971103

Mv Life LLC

Stationary oxygen concentrator

• Primary Device ID: 00860009971103
• NIH Device Record Key: 5ea0253f-6a0e-4237-b115-5754d949b386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyHome
• Version Model Number: 1400-5100
• Company DUNS: 096584064
• Company Name: Mv Life LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00860009971103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191875

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: 2023-04-05
• Device Publish Date: 2023-03-28