EyeMax2

Basic Information

• Brand Name: EyeMax2
• Primary DI: 00817770025825
• Version / Model: Preemie
• Catalog Number: R300P02-004
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: 18f4c37d-3070-4e17-9486-744f7702c4ac

Device Description

EyeMax2 Preemie Italian 20/Pack (Italian Label)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOK	Pad, Neonatal Eye	General Hospital	880.5270	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64254	Phototherapy infant blanket	A piece of fabric, made of an ultraviolet (UV) light-transmittable material, intended to be used to wrap a newborn/infant during UV phototherapy for the treatment of neonatal jaundice (neonatal hyperbilirubinemia) to enable therapeutic light to pass through to the patient while simultaneously providing comfort. It does not include a light source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817770025825	GS1