Axiom® CWV

Basic Information

• Brand Name: Axiom® CWV
• Primary DI: M66536110
• Version / Model: 3611
• 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: 2a76b320-cddb-4b58-af1e-94d00e7740eb

Device Description

Closed Wound Reservoir 150cc

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
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45391	Closed-wound drainage reservoir suction bulb	A sterile device that is used in conjunction with a drainage reservoir (typically a closed-wound type) to create a low negative pressure in the reservoir and the connected drain assisting in the removal of fluids or purulent material. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M66536113	HIBCC	Case	6	In Commercial Distribution
Package	M66536111	HIBCC	Box	10	In Commercial Distribution
Primary	M66536110	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K790654	000

Device Sizes

Type	Value	Unit	Text
Total Volume	150	Milliliter