EyeMax2

GUDID 00817770022046

Bioptron Regular EyeMax2 Single Pack

MAXTEC, LLC

Phototherapy eye protector, reusable
Primary Device ID00817770022046
NIH Device Record Key465f562d-9f26-4873-be1b-c8cc9385b132
Commercial Distribution StatusIn Commercial Distribution
Brand NameEyeMax2
Version Model NumberR300P01-006
Company DUNS169911828
Company NameMAXTEC, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817770022046 [Primary]

FDA Product Code

FOKPad, Neonatal Eye

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

On-Brand Devices [EyeMax2]

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

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