ESU TRANSILLUMINATOR

GUDID 00860003720509

The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue.

ESU LIMITED LIABILITY PARTNERSHIP

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• Primary Device ID: 00860003720509
• NIH Device Record Key: 4b95d23f-716d-4e61-8527-6e06a703adf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESU TRANSILLUMINATOR
• Version Model Number: MK-02GX
• Company DUNS: 716244660
• Company Name: ESU LIMITED LIABILITY PARTNERSHIP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003720509 [Primary]

FDA Product Code

• HJN: Transilluminator, Battery-Powered

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: 2020-05-11
• Device Publish Date: 2020-05-01