FDA.reportPublic FDA data

NeoGlo Disposable

Primary DI
10812594013062
Brand
NeoGlo Disposable
Company
Neotech Products LLC
Model
10812594013062
Catalog number
N5533WH
Device description
3 Foot Cord White Lights (Qty 10)
Published
2021-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
10812594013062PrimaryGS10
00812594013065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401306210812594013062
00812594013065008125940130658125940130650812594013065

GMDN Terms#

Term, Definition table
TermDefinition
Visible-light skin transilluminatorAn electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner.

Regulatory Flags#

DUNS number
198013435
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812594010177NeoBridge®MicoN7002021-05-19
10812594010269NeoBridge®SmallN7012021-05-19
10812594010276NeoBridge®LargeN7022021-05-19
10812594010351EZ-Hold®StandardN7572021-05-19
10812594010726NeoGrip®BlueN602B2021-05-19
10812594010740NeoGrip®Pink & BlueN6022021-05-19
10812594010764NeoGrip®VersaGrip - LargeN6012021-05-19
10812594010788NeoGrip®WhiteN6032021-05-19
10812594011037Hold-A-Line™StandardN7052021-06-02
10812594011358EZ-Hold®MiniN7562021-05-19
10812594011952Telemetry TotesClip-ToteA5012021-06-14
10812594011969Telemetry TotesValu-ToteA5072021-06-14
10812594012096EZ-Hold®Extra LargeN7582021-05-19
10812594012102NeoGrip®RedN602R2021-05-19
10812594012119NeoGrip®Neon GreenN602G2021-05-19
10812594012126NeoGrip®YellowN602Y2021-05-19
10812594012133NeoGrip®OrangeN602O2021-05-19
10812594012140NeoGrip®VioletN602V2021-05-19
10812594012461NeoGrip®PinkN602P2021-05-19
20812594012925NeoSnug Small20812594012925N7015-152023-09-08

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
B945BERAI0BernellBernellHJN2026-05-02
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
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20