Vela

Basic Information

• Brand Name: Vela
• Primary DI: 10846446001716
• Version / Model: 09413
• Catalog Number: 09413
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0eb666f5-0272-4d62-9ca3-f62a76fa1697

Device Description

WTRTRP ASSY LO-RSTNL Y

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41679	Breathing circuit condensate trap, single-use	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846446001716	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093094	000