4L

GUDID 06970076370014

4L Health Co.,Ltd.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 06970076370014
• NIH Device Record Key: 731364b8-bc07-4038-92f5-1016bae9eb6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4L
• Version Model Number: NP32
• Company DUNS: 544342742
• Company Name: 4L Health Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970076370014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113236

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [4L]

• 06970076370113: DK10AS
• 06970076370076: DK10SS
• 06970076370069: DK10MS
• 06970076370052: DK10LS
• 06970076370014: NP32