FDA.reportPublic FDA data

MDF®

Primary DI
06940211615263
Brand
MDF®
Company
MDF Instruments Medifriend Inc.
Model
MDF621BO
Device description
LUMiNiX® Professional Diagnostic Penlight, MDFBO
Published
2019-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06940211615263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06940211615263069402116152636940211615263

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

Regulatory Flags#

DUNS number
420328205
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
06940211627693MDF®MDF808M04KT22018-12-31
06940211627709MDF®MDF808MBOKT22018-12-31
06940211627761MDF®MDF808042018-09-30
06940211627969MDF®MDF808MBOKT12018-12-31
06940211628010MDF®MDF808B042018-12-31
06940211628027MDF®MDF808B082018-12-31
06940211628034MDF®MDF808B112018-12-31
06940211628041MDF®MDF808B122018-12-31
06940211628058MDF®MDF808B142018-12-31
06940211628065MDF®MDF808BBO2018-12-31
06940211628089MDF®MDF808B162018-12-31
06940211628096MDF®MDF808M042018-12-31
06940211628102MDF®MDF808M082018-12-31
06940211628119MDF®MDF808M112018-09-30
06940211628126MDF®MDF808M08KT12018-12-31
06940211628133MDF®MDF808M11KT12018-12-31
06940211628140MDF®MDF808M32KT12018-12-31
06940211628157MDF®MDF808M08KT22018-12-31
06940211628164MDF®MDF808M11KT22018-12-31
06940211628188MDF®MDF808B322018-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840113235445Bovie Fluoro-DotASPEN SURGICAL PRODUCTS, INC.KYT2026-10-21
00840113233915RN-PackASPEN SURGICAL PRODUCTS, INC.KYT2026-10-20
00840113233939High Intensity Medical Penlights DisposableASPEN SURGICAL PRODUCTS, INC.KYT2026-10-20
00840113235438Diagnostic Medical PenlightsASPEN SURGICAL PRODUCTS, INC.KYT2026-10-20
00840113236367BovieASPEN SURGICAL PRODUCTS, INC.KYT2026-10-20
08500176518382DermLite SkeenDermLite LLCKYT2026-09-28
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00814005023526RADBL25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023533RADBLC1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023540RADFILM5QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023571RADHU2QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023595RADHUM4QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023618RADINST1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024172RADC25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024189RADFILM6QUALITY ASPIRATORS, INC.KYT2025-02-27
008140050242572 Pin Detachable CableQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024288M-CZQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024295M-ORTTL AssemblyQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024301M-COQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024370M-KEQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024387M-HBQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024394M-ORQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024400M-QFQUALITY ASPIRATORS, INC.KYT2025-02-27