4L

GUDID 06970076370076

4L Health Co.,Ltd.

Negative-pressure wound therapy system dressing set

• Primary Device ID: 06970076370076
• NIH Device Record Key: 8997433f-7b3b-429d-bf91-fee712cfd1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4L
• Version Model Number: DK10SS
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	06970076370076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190119

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

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