FDA.reportPublic FDA data

EyeMax2

Primary DI
00817770020561
Brand
EyeMax2
Company
MAXTEC, LLC
Model
Kit
Catalog number
R300P16
Device description
EyeMax2 Kit(Contains a 20/pack each of Regular, Preemie, and Micro)
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOKPad, Neonatal Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOKPad, Neonatal EyeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817770020561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817770020561008177700205618177700205610817770020561

GMDN Terms#

Term, Definition table
TermDefinition
Phototherapy infant blanketA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
169911828
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817770026068Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)R229P18-0012025-07-21
00817770020691HANDI+R218P122016-09-26
00817770020707HANDI+R218P12-0012018-03-27
00817770020868Handi+ R218P12-0052016-09-24
00817770021322HANDI+, OHIO MEDICALR218P12-0122017-02-20
00817770021339HANDI+ INTERNATIONALR218P12-013R218P12-0132017-02-20
00817770024460Dual Hose10' Air/OxygenR129P272021-10-29
00817770022299Coiled Hose15 foot OxygenR127P402021-10-22
00817770024378Dual Hose10' Air/OxygenR129P182021-10-22
00817770024385Dual Hose10' Air/OxygenR129P192021-10-22
00817770024392Dual Hose10' Air/OxygenR129P202021-10-22
00817770024408Dual Hose15' Air/OxygenR129P292021-10-22
00817770024415Dual Hose15' Air/OxygenR129P222021-10-22
00817770024422Dual Hose15' Air/OxygenR129P232021-10-22
00817770024439Dual Hose15' Air/OxygenR129P242021-10-22
00817770024446Dual Hose10' Air/OxygenR129P252021-10-22
00817770024453Dual Hose10' Air/OxygenR129P262021-10-22
00817770024477Dual Hose6' Air/OxygenR129P502021-10-22
00817770024484Dual Hose6' Air/OxygenR129P512021-10-22
00817770024491Dual Hose6' Air/OxygenR129P522021-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315011764BilibandNatus Medical Denmark ApSFOK2025-10-14
05713315011771BilbandNatus Medical Denmark ApSFOK2025-10-14
05713315011788BilibandNatus Medical Denmark ApSFOK2025-10-14
00850018561273WeeSpecs Infant Eye ProtectionINTERNATIONAL BIOMEDICAL, LTD.FOK2023-06-21
00817770025818EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025825EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025832EyeMax2MAXTEC, LLCFOK2023-06-12
10190676001931POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001948POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001938POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001945POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001924POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00190676001927POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00817770022411EyeMax2MAXTEC, LLCFOK2021-10-25
00749756139588DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139595DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139601DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139618DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139625DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756173872DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562515DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562522DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139583DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139590DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139606DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139613DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139620DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756173877DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756562510DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756562527DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12