Axiom® Mills Sump Atraum™ With ClotStop®

Basic Information

• Brand Name: Axiom® Mills Sump Atraum™ With ClotStop®
• Primary DI: M665111169AT0
• Version / Model: 111169AT
• Company Name: AXIOM MEDICAL, INCORPORATED
• Labeler DUNS: 094439676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-23
• Public Version: 1
• Public Version Date: 2018-10-24
• Public Version Status: New
• Public Device Record Key: 897e3848-fdd6-4f20-be71-e3b5a6176424

Device Description

Dual Lumen, Mediastinal, Round, Silicone, Open Tip, With ClotStop®

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15270	Sump drain	A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M665111169AT3	HIBCC	Case	6	In Commercial Distribution
Package	M665111169AT1	HIBCC	Box	10	In Commercial Distribution
Primary	M665111169AT0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K883887	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	28	French