Home GUDID 10812594010221 NeoShades® with Tabs
Primary DI 10812594010221
Brand NeoShades® with Tabs
Company Neotech Products LLC
Model Micro
Catalog number N720
Device description The NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients.
Published 2021-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name FOK Pad, Neonatal Eye
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FOK Pad, Neonatal Eye General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10812594010221 Primary GS1 0 00812594010224 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10812594010221 10812594010221 00812594010224 00812594010224 812594010224 0812594010224
GMDN Terms# Term, Definition table Term Definition Eye mask A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.
Regulatory Flags# DUNS number 198013435 Device count 50 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05713315011764 Biliband Natus Medical Denmark ApS FOK 2025-10-14 05713315011771 Bilband Natus Medical Denmark ApS FOK 2025-10-14 05713315011788 Biliband Natus Medical Denmark ApS FOK 2025-10-14 00850018561273 WeeSpecs Infant Eye Protection INTERNATIONAL BIOMEDICAL, LTD. FOK 2023-06-21 00817770020561 EyeMax2 MAXTEC, LLC FOK 2023-06-12 00817770025818 EyeMax2 MAXTEC, LLC FOK 2023-06-12 00817770025825 EyeMax2 MAXTEC, LLC FOK 2023-06-12 00817770025832 EyeMax2 MAXTEC, LLC FOK 2023-06-12 10190676001931 POSEY POSEY PRODUCTS, LLC FOK 2022-10-06 10190676001948 POSEY POSEY PRODUCTS, LLC FOK 2022-10-06 20190676001938 POSEY POSEY PRODUCTS, LLC FOK 2022-10-06 20190676001945 POSEY POSEY PRODUCTS, LLC FOK 2022-10-06 10190676001924 POSEY EYE PROTECTORS POSEY PRODUCTS, LLC FOK 2022-08-04 00190676001927 POSEY EYE PROTECTORS POSEY PRODUCTS, LLC FOK 2022-08-04 00817770022411 EyeMax2 MAXTEC, LLC FOK 2021-10-25 00749756139588 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756139595 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756139601 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756139618 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756139625 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756173872 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756562515 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 00749756562522 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756139583 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756139590 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756139606 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756139613 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756139620 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756173877 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12 50749756562510 DeRoyal DEROYAL INDUSTRIES, INC. FOK 2021-07-12