4L

Basic Information

• Brand Name: 4L
• Primary DI: 06970076370014
• Version / Model: NP32
• Company Name: 4L Health Co.,Ltd.
• Labeler DUNS: 544342742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-15
• Public Version: 1
• Public Version Date: 2020-06-23
• Public Version Status: New
• Public Device Record Key: 731364b8-bc07-4038-92f5-1016bae9eb6d

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47408	Negative-pressure wound therapy system pump, electric	A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970076370014	GS1

Premarket Submissions

Submission Number	Supplement Number
K113236	000