Ergoline Vitality Pure Light 3 (10 min)

GUDID EJKP100004042A0

JK-Products GmbH

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• Primary Device ID: EJKP100004042A0
• NIH Device Record Key: 57dc91fc-25d9-469f-b1a9-e1916b763230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergoline Vitality Pure Light 3 (10 min)
• Version Model Number: JK 164 / 50-4 PLT-3 AC
• Company DUNS: 316232073
• Company Name: JK-Products GmbH
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EJKP100004042A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220500

FDA Product Code

• LEJ: Booth, Sun Tan

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: 2024-03-07
• Device Publish Date: 2024-02-28

Devices Manufactured by JK-Products GmbH

• EJKP100004042A0 - Ergoline Vitality Pure Light 3 (10 min): 2024-03-07
• EJKP100004042A0 - Ergoline Vitality Pure Light 3 (10 min): 2024-03-07
• EJKP100003952B0 - Revive: 2023-12-11
• EJKP100003960B0 - Revive RVT30: 2023-12-11
• EJKP100003973A0 - Revive PRO IR: 2023-11-23
• EJKP100003892A0 - VITALITY 46/3 PLT AC USA: 2023-06-08
• EJKP100003946A0 - Ergoline/PASSION PLUS 40/3 Smart Performance: 2023-06-08
• EJKP100003952A0 - Revive 7200: 2023-06-08
• EJKP100003960A0 - Revive RVT30: 2023-05-08