FDA.reportPublic FDA data

WeeSpecs Infant Eye Protection

Primary DI
00850018561273
Brand
WeeSpecs Infant Eye Protection
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
WeeSpecs
Device description
Phototherapy Mask
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850018561273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018561273008500185612738500185612730850018561273

GMDN Terms#

Term, Definition table
TermDefinition
Eye maskA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561099Wee Sight Transilluminator 9898056037612023-06-20
00865648000306Aviator Transport IncubatorAviator2023-06-20
00865648000320Voyager Infant Transport IncubatorVoyager2023-06-20
00868406000099185A+ Infant Incubator185A+2023-06-20
00850018561020NxtGen Infant Transport IncubatorNxtGen732-00002023-04-07
00850018561013NxtGen Infant Transport IncubatorNxtGen738-21342022-10-27
00868406000006Aviator Transport IncubatorAviator2016-09-27
00868406000013A750i Infant IncubatorA750i2016-09-27
00868406000020Voyager Infant Transport IncubatorVoyager2016-09-27
00868406000037185A+ Infant Incubator185A+2016-09-27
00850018561204LC Accu-Bar Temperature Trend Indicator9898056230012023-06-20
00850018561594Infant Heel Warmer122312232023-06-20
00850018561600Infant Heel Snuggler99047990472023-06-20
00850018561648NeoPod T, Neonatal Transport Humidification System940094002023-06-20
00865648000313NuBorne Infant WarmerWarmer2023-06-20
00865648000344Puffin Lite Infant ResuscitatorPuffin2023-06-20
00850018561587Infa-Therm Mattress101510152023-04-07
00865648000337AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx 2.0731-91592021-06-21
00868406000051LifeBorne Puffin Infant Resuscitator738-1099738-10992016-09-26
00868406000068AeroNOx Nitric Oxide Delivery DeviceAeroNOx731-91482016-09-26

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
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
50749756562527DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12