Ergoline/PASSION PLUS 40/3 Smart Performance

GUDID EJKP100003947A0

JK-Products GmbH

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• Primary Device ID: EJKP100003947A0
• NIH Device Record Key: b41fbbbf-a887-4924-8883-b3f25cfb0201
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergoline/PASSION PLUS 40/3 Smart Performance
• Version Model Number: JK 103 / 40-3 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	EJKP100003947A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151400

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: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [Ergoline/PASSION PLUS 40/3 Smart Performance]

• EJKP100003947A0: JK 103 / 40-3 AC
• EJKP100003946A0: JK 103 / 40-3