EyeMax2 R300P01-004

GUDID 00817770025832

EyeMax2 Regular 20/Pack (Italian Label)

MAXTEC, LLC

Phototherapy infant blanket

• Primary Device ID: 00817770025832
• NIH Device Record Key: 288efa7a-2ed5-4679-b985-7701706aba56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EyeMax2
• Version Model Number: Regular
• Catalog Number: R300P01-004
• Company DUNS: 169911828
• Company Name: MAXTEC, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770025832 [Primary]

FDA Product Code

• FOK: Pad, Neonatal Eye

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [EyeMax2]

• 00817770021841: Micro 20/Pack
• 00817770021834: Preemie 20/pack
• 00853061006920: Regular 20/pack
• 00817770022169: Ecuador Micro EyeMax2 20/Pack
• 00817770022152: Drager MP03770 Micro EyeMax2 20/pack
• 00817770022145: USA Micro EyeMax2 20/Pack
• 00817770022138: Mediprema Micro EyeMax2 20/Pack
• 00817770022121: Ecuador Preemie EyeMax2 20/Pack
• 00817770022114: Drager MP03771 Preemie EyeMax2 20/Pack
• 00817770022107: USA Preemie EyeMax2 20/pack
• 00817770022091: Mediprema Preemie EyeMax2 20/Pack
• 00817770022084: Fisher & Paykel Preemie EyeMax2 20/pack
• 00817770022077: Ecuador Regular EyeMax2 20/Pack
• 00817770022060: Drager MP03772 Regular EyeMax2 20/Pack
• 00817770022053: USA Regular EyeMax2 20/pack
• 00817770022046: Bioptron Regular EyeMax2 Single Pack
• 00817770022039: Mediprema Regular EyeMax2 20/Pack
• 00817770022022: Fisher & Paykel Regular EyeMax2 20/Pack
• 00817770022411: Micro EyeMax2 20/pack Fisher & Paykel
• 00817770025832: EyeMax2 Regular 20/Pack (Italian Label)
• 00817770025825: EyeMax2 Preemie Italian 20/Pack (Italian Label)
• 00817770025818: EyeMax2 Micro 20/Pack Italian (Italian Label)
• 00817770020561: EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro)