Axiom® MultiPurpose Atraum™ With ClotStop®

Basic Information

• Brand Name: Axiom® MultiPurpose Atraum™ With ClotStop®
• Primary DI: M665110218AT0
• Version / Model: 110218AT
• Company Name: AXIOM MEDICAL, INCORPORATED
• Labeler DUNS: 094439676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b0ae6253-0c96-4e10-b492-782a78990e3e

Device Description

Sump Drain, Two Lumens, Silicone, Splittable, 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
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	868.5120	2

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	M665110218AT3	HIBCC	Case	6	In Commercial Distribution
Package	M665110218AT1	HIBCC	Box	10	In Commercial Distribution
Primary	M665110218AT0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993592	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 FR