FDA.reportPublic FDA data

Bili-Bonnet

Primary DI
00815090010019
Brand
Bili-Bonnet
Company
SMALL BEGINNINGS INC
Model
01B
Catalog number
01B
Device description
Bili-Bonnet Newborn 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
OTC
true
Single use
true

Contact Domains#

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
10815090010016PackageGS150In Commercial Distribution
20815090010013PackageGS14In Commercial Distribution
00815090010019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001001610815090010016
2081509001001320815090010013
00815090010019008150900100198150900100190815090010019

GMDN Terms#

Term, Definition table
TermDefinition
Eye padA 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.

Contacts#

Phone, Email table
PhoneEmail
760-949-7707kelly@small-beginnings.com

Regulatory Flags#

DUNS number
002657679
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815090013409AP Onkers16-716-72022-12-15
00815090012426Tender and Tiny Tourniquets11TA11TA2020-08-03
00815090012464Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090010026Pacee Pacifier15A15A2020-09-24
10815090010023Pacee Pacifier15A15A2020-09-24
00815090010002Bili-Bonnet01A01A2020-08-03
00815090010170Bili-Bonnet01C01C2020-08-03
10815090010009Bili-Bonnet01A01A2020-08-03
10815090010016Bili-Bonnet01B01B2020-08-03
10815090010177Bili-Bonnet01C01C2020-08-03
00815090012785Tender and Tiny Tourniquets11TA11TA2020-08-03
10815090012461Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090011436Webeonkers16-016-02020-06-23
10815090011433Webeonkers16-016-02020-06-23
00815090010040Bebeonkers II16-216-22016-09-24
00815090010057Bebeonkers I16-116-12016-09-24
00815090010064Bebe Keeper Kover16-316-32016-09-24
00815090011382Bebeonkers II16-2KK16-2KK2016-09-24
00815090011535Webeonkers16-0KK16-0KK2016-09-24
00815090011740Bebeonkers I16-1KK16-1KK2016-09-24

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
00817770020561EyeMax2MAXTEC, LLCFOK2023-06-12
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