Axiom® CWV Atraum™ With ClotStop®

Basic Information

• Brand Name: Axiom® CWV Atraum™ With ClotStop®
• Primary DI: M665803631AT0
• Version / Model: 803631AT
• 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: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: c927e033-d8dc-4483-bfec-655d21017bc8

Device Description

Closed Wound Drain, Flat, Silicone, With Trocar, 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
GBX	Catheter, Irrigation	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11305	Closed-wound drain, non-bioabsorbable	A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any 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	M665803631AT3	HIBCC	Case	10	In Commercial Distribution
Package	M665803631AT1	HIBCC	Box	10	In Commercial Distribution
Primary	M665803631AT0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K965146	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7 mm