Home GUDID 10815090010177 Bili-Bonnet
Primary DI 10815090010177
Brand Bili-Bonnet
Company SMALL BEGINNINGS INC
Model 01C
Catalog number 01C
Device description Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice.
Published 2020-08-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
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 10815090010177 Package GS1 50 In Commercial Distribution 20815090010174 Package GS1 4 In Commercial Distribution 00815090010170 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10815090010177 10815090010177 20815090010174 20815090010174 00815090010170 00815090010170 815090010170 0815090010170
GMDN Terms# Term, Definition table Term Definition Eye pad A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 002657679 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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
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