PEGASUS P23001

GUDID 00612223230012

HUMIDIFIER HEATER BRACKET, VISION/PHILIPSV60 FIT

PEGASUS RESEARCH CORPORATION

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

• Primary Device ID: 00612223230012
• NIH Device Record Key: 0ecbb05a-fbff-4858-a9f9-69444f3fe6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEGASUS
• Version Model Number: P23001
• Catalog Number: P23001
• 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: 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: false
• OTC Over-The-Counter: true

Device Dimensions

• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch
• Length: 5 Inch
• Height: 2.5 Inch
• Width: 2.8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223230012 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-24
• Device Publish Date: 2021-09-16

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