Axiom® Atraum™ With ClotStop®

Basic Information

• Brand Name: Axiom® Atraum™ With ClotStop®
• Primary DI: M665111120ATSC0
• Version / Model: 111120ATSC
• 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: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 5fa26b38-59c7-450f-8359-03d9ddd93a12

Device Description

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, 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
37482	Pleural catheter	A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M665111120ATSC3	HIBCC	Case	6	In Commercial Distribution
Package	M665111120ATSC1	HIBCC	Box	10	In Commercial Distribution
Primary	M665111120ATSC0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K883887	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 FR