SIS Adaptor

Basic Information

• Brand Name: SIS Adaptor
• Primary DI: 00857136004170
• Version / Model: STA-0001
• Company Name: SUREFIRE MEDICAL, INC.
• Labeler DUNS: 832575497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-20
• Public Version: 3
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 119057c2-8fc7-49e3-a63f-c70f19fc4e3f

Device Description

Surefire Infusion System Adaptor

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: 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
FOX	Stand, Infusion	General Hospital	880.6990	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857136004170	GS1