Kernel

GUDID 06928798600070

Xuzhou Kernel Medical Equipment Co., Ltd.

Ultraviolet phototherapy unit, home-use

• Primary Device ID: 06928798600070
• NIH Device Record Key: cca5b441-7eb5-46d3-934e-b900895726fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kernel
• Version Model Number: KN-4003AL2
• Company DUNS: 530873660
• Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06928798600070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181805

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

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: 2019-03-18
• Device Publish Date: 2019-03-08

On-Brand Devices [Kernel]

• 06928798600285: KN-2200BI
• 06928798600278: KN-2200B
• 06928798600261: KN-2200I(H）
• 06928798600254: KN-2200I
• 06928798600247: KN-2200A
• 06928798600230: KN-2200
• 06928798600223: KN-4006BL1DS
• 06928798600216: KN-4006AL1DS
• 06928798600209: KN-4006BL1S
• 06928798600193: KN-4006AL1S
• 06928798600186: KN-4006BL1D
• 06928798600179: KN-4006AL1D
• 06928798600162: KN-4006BL1
• 06928798600155: KN-4006AL1
• 06928798600148: KN-4003BL2DS
• 06928798600131: KN-4003AL2DS
• 06928798600124: KN-4003BL2S
• 06928798600117: KN-4003AL2S
• 06928798600100: KN-4003BL2D
• 06928798600094: KN-4003AL2D
• 06928798600087: KN-4003BL2
• 06928798600070: KN-4003AL2
• 06928798600063: KN-4006BL
• 06928798600056: KN-4006B
• 06928798600049: KN-4006AL
• 06928798600032: KN-4003BL
• 06928798600025: KN-4003B
• 06928798600018: KN-4003AL
• 06928798600292: KN-8000A
• 06928798600360: It is hair growing system for OTC use
• 06928798600353: It is hair grow system for OTC
• 06928798600346: It is hair growing system for OTC use
• 06928798600339: It is hair growing system for OTC use
• 06928798600414: The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It
• 06928798600407: The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It
• 06928798600513: KN-7000L
• 06928798600452: KN-5000D
• 06928798600445: KN-5000C
• 06928798600438: KN-5000K
• 06928798600421: KN-5000H
• 06928798600391: KN-4003B4
• 06928798600384: KN-4003B3
• 06928798600377: CN-308E