FLYp

Basic Information

• Brand Name: FLYp
• Primary DI: 00869112000175
• Version / Model: 0001
• Company Name: CONVEXITY SCIENTIFIC LLC
• Labeler DUNS: 081072216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-08
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2ace3a35-275a-4ab1-b711-2fc6ea12917d

Device Description

Hypersoniq PDA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61167	Nebulizing adaptor	A non-powered small connecting device, which includes an integrated nebulizer, intended to join a sterile water or sterile isotonic sodium chloride solution reservoir to a respiratory gas source (typically wall outlet) and a gas administration device (e.g., mask, mouthpiece). It is designed to generate aerosolized fluid (finely dispersed airborne droplets in a liquid phase) to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869112000175	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: -10 – 45 Degrees Celsius