CURAPLEX RES-Q P3100NAC

GUDID 612223310134

CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM

PEGASUS RESEARCH CORPORATION

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