RES-Q P3100NA

GUDID 612223310127

CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM

PEGASUS RESEARCH CORPORATION

Nebulizing adaptor

• Primary Device ID: 612223310127
• NIH Device Record Key: 7380b9a1-4aa7-4a8a-a2cf-ace3ab7bc545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RES-Q
• Version Model Number: P3100NA
• Catalog Number: P3100NA
• 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: 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

• Height: 3.5 Inch
• Height: 3.5 Inch
• Height: 3.5 Inch
• Height: 3.5 Inch
• Height: 3.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 8 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223310172 [Primary]
GS1	612223310127 [Package]; Contains: 00612223310172; Package: CA [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122857

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

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• 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