FISSO

Basic Information

• Brand Name: FISSO
• Primary DI: 07640152573170
• Version / Model: 3590.01-4087
• Company Name: Baitella AG
• Labeler DUNS: 484942081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-30
• Public Version: 3
• Public Version Date: 2023-02-01
• Public Version Status: Update
• Public Device Record Key: 614ad3c8-9d90-438d-962f-4043f2e24ded

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	868.5975	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37041	Breathing circuit tube holder	A device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640152573170	GS1

Customer Contacts

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