CURAPLEX P3000NB

GUDID 00612223030315

ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM AND 500ML BOTTLE COMBINATION

PEGASUS RESEARCH CORPORATION

Nebulizing adaptor

• Primary Device ID: 00612223030315
• NIH Device Record Key: 417e12a8-bbc5-4bcb-a124-ba026be63bf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURAPLEX
• Version Model Number: 301-P3000NB
• Catalog Number: P3000NB
• 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

• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch
• Outer Diameter: 2.5 Inch
• Height: 3.5 Inch
• Length: 14.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223030315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893942

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: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [CURAPLEX]

• 612223310226: CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM, LONG TUBE
• 00612223310264: CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
• 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