PEGASUS P2001

GUDID 00612223200015

NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER

PEGASUS RESEARCH CORPORATION

Nebulizing system, heated

• Primary Device ID: 00612223200015
• NIH Device Record Key: edddbc6a-d998-4624-a094-b69ec5bb3d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEGASUS
• Version Model Number: P2001
• Catalog Number: P2001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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 Inch
• Outer Diameter: 4 Inch
• Outer Diameter: 4 Inch
• Outer Diameter: 4 Inch
• Outer Diameter: 4 Inch
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch
• Height: 4.5 Inch
• Weight: 3 Pound
• Outer Diameter: 4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223200015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880473

FDA Product Code

• CAF: Nebulizer (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: 2016-09-23

On-Brand Devices [PEGASUS]

• 00612223200015: NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
• 00612223261009: NEBULIZER HEATER ADAPTER
• 00612223260002: CURAPLEX HEATER CORE FOR 301-P2000
• 00612223230012: HUMIDIFIER HEATER BRACKET, VISION/PHILIPSV60 FIT
• 00612223230005: HUMIDIFIER HEATER BRACKET
• 00612223701000: NEBULIZER HEATER ADAPTER GASKET
• 00612223063009: FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT
• 00612223062507: FLO2 STANDARD FLOW OXYGEN DILUTER
• 00612223062002: FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT
• 00612223061005: FLO2 HIGH FLOW OXYGEN DILUTER, PEDIATRIC KIT
• 00612223060503: FLO2 HIGH FLOW OXYGEN DILUTER
• 00612223060008: FLO2 HIGH FLOW OXYGEN DILUTER, ADULT KIT