FireSafe Cannula Kit

Basic Information

• Brand Name: FireSafe Cannula Kit
• Primary DI: 00848530104917
• Version / Model: AMRS001FiresafeKit
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-14
• Public Version: 1
• Public Version Date: 2025-04-22
• Public Version Status: New
• Public Device Record Key: 93fb2d90-39b7-4a57-b12e-4c3b5c2ce12d

Device Description

FireSafe Kit This Kit Contains: 3 - RES010 Firesafe Cannula Valve, 2 - RES010TC Firesafe Connector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60391	Oxygen tubing fire safety valve	A safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530104917	GS1

Customer Contacts

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