THERMAGARD P20001H

GUDID 00612223057053

NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER

PEGASUS RESEARCH CORPORATION

Nebulizing system, heated Nebulizing system, heated Nebulizing system, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated

• Primary Device ID: 00612223057053
• NIH Device Record Key: c91a2c92-9053-4c78-a047-847188051a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMAGARD
• Version Model Number: 5705
• Catalog Number: P20001H
• 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	00612223057053 [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

Devices Manufactured by PEGASUS RESEARCH CORPORATION

• 00612223060008 - PEGASUS: 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER, ADULT KIT
• 00612223060503 - PEGASUS: 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER
• 00612223061005 - PEGASUS: 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER, PEDIATRIC KIT
• 00612223062002 - PEGASUS: 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT
• 00612223062507 - PEGASUS: 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER
• 00612223063009 - PEGASUS: 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT
• 00612223700010 - MISTIC: 2021-09-27 NEBULIZER,BARREL REUSABLE BOTTLE 1000ML
• 00612223701000 - PEGASUS: 2021-09-27 NEBULIZER HEATER ADAPTER GASKET