FDA.reportPublic FDA data

Fortuna

Primary DI
00888937020182
Brand
Fortuna
Company
RESEARCH INSTRUMENTS LIMITED
Model
FORTUNA 1500LE IVF 240V SERIAL NUMBER
Catalog number
WF1500LE-W5240
Device description
In Vitro Fertilization IVF Workstation
Published
2024-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PUBAccessory, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUBAccessory, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937020182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937020182008889370201828889370201820888937020182

GMDN Terms#

Term, Definition table
TermDefinition
Class-I biological safety cabinetA furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens). It typically utilizes laminar airflow (LAF), a high-efficiency particulate air (HEPA) filter and/or carbon filter, and may have a hydrogen peroxide (H2O2) connection as some of the protective mechanisms. It is used for handling cell cultures and human pathogens (e.g., bacteria, viruses, parasites) and other biohazardous materials, extremely toxic agents (e.g., chemotherapy drugs), and also for tissue culture and tumour virus work.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
536139413
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060554120956K-SystemsG210 InviCellK595002025-02-25
05060554120963K-SystemsG210 InviCellK595002025-02-25
00888937014488TITANTITAN WTIVFE IVF 120V SERIAL NUMBERWTIVFE-W51202024-09-20
00888937014587MARSMARS 1800 IVF WS 6FT W/RIGHT ELEC HEATWM1800RE2024-09-20
00888937014600MARSMARS 1800 IVF WS 6FT W/LEFT ELEC HEATWM1800LE2024-09-20
00888937014648MARSMARS 1800 MULTI ELEC WS 6FT ANTIVIBRATIONWM1800MPE2024-09-20
00888937014655TITANTITAN IVF FIXED STAND 75-80CMWTIVFE2024-09-20
00888937014662TITANTITAN WTIVFEADJ IVF 120V SERIAL NUMBERWTIVFEADJ-W51202024-09-20
00888937014679TITANTITAN IVF ADJUSTABLE HEIGHTWTIVFEADJ2024-09-20
00888937020243MARSMARS 900E IVF 240V SERIAL NUMBERWM900E-W52402024-09-20
00888937020281MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800DE-W52402024-09-20
00888937020298MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800LE-W52402024-09-20
00888937020304MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800MPE-W52402024-09-20
00888937020311MARSMARS 1800RE IVF 240V SERIAL NUMBERWM1800RE-W52402024-09-20
00888937020328TITANTITAN WTIVFE IVF 240V SERIAL NUMBERWTIVFE-W52402024-09-20
00888937020335TITANTITAN WTIVFEADJ IVF 240V SERIAL NUMBERWTIVFEADJ-W52402024-09-20
00888937024685MARSMARS 900 LAF 3FT MARS WORKSTATIONWM9002024-09-20
00888937024722TITANTITAN LAF BENCHTOP MODELWTLAF2024-09-20
05060554120024CODAK59549 Coda Inline Filter for G185 USK595492024-09-20
05060554120086G185K22400-110 G185 Standard 110V Incubator ROWK22400-1102024-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04779041940168Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940199Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940267Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940311MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940809Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940816Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940243Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940465Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940472Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940496Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940502Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940519Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940526Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940533Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940540Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940557Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940564Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940700Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04580647510125EC10-120MDASTEC CO.,LTD.PUB2026-01-12
04779041940458Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-12
04779041940441Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-07
06975183900062HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900079HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900086HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900093HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
05060554120956K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
05060554120963K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
00888937014488TITANRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014587MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014600MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20