Axiom®

Basic Information

• Brand Name: Axiom®
• Primary DI: M665515NS0
• Version / Model: 515NS
• Company Name: AXIOM MEDICAL, INCORPORATED
• Labeler DUNS: 094439676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: af855124-6dcb-4cf4-a533-988dc4ffb3f2

Device Description

Non Sterile Continuous Tubing

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Radiation Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16779	Suction/irrigation tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M665515NS1	HIBCC	Bag	1	In Commercial Distribution
Primary	M665515NS0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.5	Inch
Outer Diameter	0.6875	Inch
Device Size Text, specify			Wall: 0.09375in.
Length	50	Feet