O2asis Humidifier

GUDID 00810020360813

O2asis Pediatric Cannula Consumable of O2asis Humidifier

PERMA PURE LLC

Heated respiratory humidifier

• Primary Device ID: 00810020360813
• NIH Device Record Key: 3c566a24-23d7-4ba6-a86d-bf1f59602636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2asis Humidifier
• Version Model Number: Pediatric Cannula
• Company DUNS: 063142533
• Company Name: PERMA PURE LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00810020360813 [Package]; Contains: 00840106905645; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	00840106905645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193411

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (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: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [O2asis Humidifier]

• 00810020360813: O2asis Pediatric Cannula Consumable of O2asis Humidifier
• 00840106905492: O2asis Humidifier Kit
• 10840106905475: O2asis Humidifier Base Unit
• 00840106905461: O2asis Humidifier Water Well
• 00810020360745: O2asis Humidifier Water Pump
• 00840106905447: O2asis Cannula Adult Replacement consumable for the O2asis Humidifier