CURAPLEX 301-P3000BH

GUDID 00612223300296

CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, PACKAGED WITH 500ML BOTTLE

PEGASUS RESEARCH CORPORATION

Nebulizing adaptor

• Primary Device ID: 00612223300296
• NIH Device Record Key: 124f24b9-a483-4990-8ffc-256de69a76e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURAPLEX
• Version Model Number: P3000BHC
• Catalog Number: 301-P3000BH
• 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

• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223300296 [Primary]
GS1	612223300241 [Package]; Package: CA [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962534

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: 2016-09-24

On-Brand Devices [CURAPLEX]

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• 612223310110: CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
• 00612223300296: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, PACKAGED WITH 500ML BOTTLE
• 612223300234: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM
• 612223300227: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, LONG TUBE, UP TO 40 LPM
• 612223300210: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM
• 612223300128: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, SHORT TUBE
• 612223300111: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, LONG TUBE
• 612223300104: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
• 00612223200114: NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
• 00612223020002: CURAPLEX HUMIDIFIER HEATER, 115V
• 00612223200121: NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER, AIRLIFE FIT
• 00612223030346: CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, WITH 500ML BOTTLE COMBINATION
• 00612223030322: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, WITH 500ML BOTTLE COMBINATION
• 00612223030315: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM AND 500ML BOTTLE COMBINATION
• 00612223030278: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM, AIRLIFE FIT
• 00612223030254: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, LONG TUBE, UP TO 40 LPM, AIRLIFE FIT
• 00612223030230: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, AIRLIFE FIT
• 00612223030148: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, SHORT TUBE, AIRLIFE FIT
• 00612223030124: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, LONG TUBE, AIRLIFE FIT
• 00612223030100: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT
• 00612223013103: WICK HUMIDIFIER, AIRLIFE FIT
• 00612223001339: ENTRAINMENT WICK HUMIDIFIER
• 00612223001315: WICK HUMIDIFIER
• 00612223262006: CURAPLEX NEBULIZER HEATER ADAPTER, AIRLIFE FIT
• 00612223261016: CURAPLEX NEBULIZER HEATER ADAPTER
• 00612223260026: CURAPLEX HEATER CORE FOR 301-P2000, AIR LIFE FIT
• 00612223260019: CURAPLEX HEATER CORE FOR 301-P2000