MISTIC P3500

GUDID 612223035006

HUMIDIFIER

PEGASUS RESEARCH CORPORATION

Heated respiratory humidifier

• Primary Device ID: 612223035006
• NIH Device Record Key: fed9f84f-93e9-4a76-81f7-cc2fb0183869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MISTIC
• Version Model Number: P3500
• Catalog Number: P3500
• Company DUNS: 185432994
• Company Name: PEGASUS RESEARCH CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 4.125 Inch
• Outer Diameter: 4.125 Inch
• Outer Diameter: 4.125 Inch
• Outer Diameter: 4.125 Inch
• Outer Diameter: 4.125 Inch
• Outer Diameter: 4.125 Inch
• Length: 12 Inch
• Height: 4.5 Inch
• Outer Diameter: 4.125 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223035013 [Primary]
GS1	612223035006 [Package]; Contains: 00612223035013; Package: CA [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894000

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

On-Brand Devices [MISTIC]

• 00612223310257: CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
• 612223310103: CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
• 612223300319: ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, AIRLIFE FIT
• 00612223300357: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT
• 00612223300258: ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM
• 612223300005: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
• 612223035006: HUMIDIFIER
• 612223030216: ENTRAINMENT NEBULIZER WITH GASKET, HIGH FLOW, UP TO 40 LPM, SAP CANADA,
• 00612223700010: NEBULIZER,BARREL REUSABLE BOTTLE 1000ML