CURAPLEX RES-Q P3100NAC

GUDID 612223310134

CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM

PEGASUS RESEARCH CORPORATION

Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor

• Primary Device ID: 612223310134
• NIH Device Record Key: 0ebb1eaa-871a-4593-800b-f5d382a33f1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURAPLEX RES-Q
• Version Model Number: 301-0909
• Catalog Number: P3100NAC
• 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: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch
• Height: 3.5 Inch
• Outer Diameter: 2.5 Inch
• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223310189 [Primary]
GS1	612223310134 [Package]; Contains: 00612223310189; 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

On-Brand Devices [CURAPLEX RES-Q]

• 612223310233: CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH PEDIATRIC MASK
• 00612223310196: CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH ADULT MASK
• 612223310134: CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM