FDA.reportPublic FDA data

Bernell

Primary DI
B945BERAI0
Brand
Bernell
Company
Bernell
Model
BERAI
Catalog number
BERAI
Device description
Bernell After Image Generator
Published
2026-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HJNTransilluminator, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B945BERAI0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training chartAn ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.

Regulatory Flags#

DUNS number
175947340
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B945BC10420BernellBC1042BC10422026-05-02
B945BC10440BernellBC1044BC10442026-05-02
B945BC12701000BernellBC1270100BC12701002026-05-03
B945BC1270100NI0BernellBC1270100NIBC1270100NI2026-05-03
B945BC12701250BernellBC1270125BC12701252026-05-03
B945BC1270125NI0BernellBC1270125NIBC1270125NI2026-05-03
B945BC12701500BernellBC1270150BC12701502026-05-03
B945BC1270150NI0BernellBC1270150NIBC1270150NI2026-05-03
B945BC12701750BernellBC1270175BC12701752026-05-03
B945BC1270175NI0BernellBC1270175NIBC1270175NI2026-05-03
B945BC12702000BernellBC1270200BC12702002026-05-03
B945BC1270200NI0BernellBC1270200NIBC1270200NI2026-05-03
B945BC12702250BernellBC1270225BC12702252026-05-03
B945BC1270225NI0BernellBC1270225NIBC1270225NI2026-05-03
B945BC1270250BernellBC127025BC1270252026-05-03
B945BC12702500BernellBC1270250BC12702502026-05-03
B945BC1270250NI0BernellBC1270250NIBC1270250NI2026-05-03
B945BC127025500BernellBC12702550BC127025502026-05-03
B945BC12702550NI0BernellBC12702550NIBC12702550NI2026-05-03
B945BC127025NI0BernellBC127025NIBC127025NI2026-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544050zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544678zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544692zumaxZumax Medical Co., LTDHJN2026-05-21
B945MTBIFL0BernellBernellHJN2026-05-02
B945MTBIH20BernellBernellHJN2026-05-02
00697077003166Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
00697077003173Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2025-07-17
00850064466348VF1000LED Vein locatorFABINJECT LLCHJN2025-03-02
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00732094074130Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074185Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074192Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082708Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082715Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082739Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
04260114140214ASTODIAStihler Electronic GmbHHJN2023-07-18
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2022-12-21
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
10812594013000NeoGlo DisposableNeotech Products LLCHJN2021-05-20
10812594013062NeoGlo DisposableNeotech Products LLCHJN2021-05-20
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20