FDA.report

FUJIFILM

Primary DI
04547410330243
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EN-580T
Device description
The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation,
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FDAEnteroscope and accessories
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14547410330240PackageGS11In Commercial Distribution
04547410330243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1454741033024014547410330240
04547410330243045474103302434547410330243

GMDN Terms

TermDefinition
Flexible video enteroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy typically to examine strictures, assess Crohn's's disease, or take biopsies. It may be designed to be manually inserted or may be designed with features to assist/power insertion (e.g., push/pull double-balloons, powered spiralling motor). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00There must be no condensation.
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide;High-level Disinfectant

Contacts

PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04547410571134FDR AQRODR-XD 1000 MBL ES US E2026-03-20
14547410566250FUJIFILMDH-084STR2026-02-27
14547410566298FUJIFILMDH-094STR2026-02-27
14547410566335FUJIFILMDH-104STR2026-02-27
14547410566373FUJIFILMDH-114STR2026-02-27
14547410566410FUJIFILMDH-124STR2026-02-27
14547410566458FUJIFILMDH-134STR2026-02-27
14547410520580FUJIFILMEB-710US2026-01-23
14547410564119FUJIFILMKE-007D2025-10-24
04547410565195ECHELON SynergyMR-TSP-156BECHELON Synergy Spine Coil B2025-11-30
04547410484786FDR D-EVO III G35iDR-ID 1831 SE MDR E2025-08-29
04547410484793FDR D-EVO III G43iDR-ID 1832 SE MDR E2025-08-29
04547410484809FDR D-EVO III C35iDR-ID 1811 SE MDR E2025-08-29
04547410484816FDR D-EVO III C43iDR-ID 1812 SE MDR E2025-08-29
04547410484823FDR D-EVO III C25iDR-ID 1814 SE MDR E2025-08-29
04547410511673FDR D-EVO III G80iDR-ID 1836 SE MDR E2025-08-29
04547410515176DR-ID 1200MCDR-ID 1200 MC SOFT KIT MDR E2025-08-29
14547410477242FUJIFILMEC-860S/L2025-06-30
14547410477273FUJIFILMEC-860P/M2025-06-30
14547410477303FUJIFILMEC-860P/L2025-06-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04953170467349ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-09-25
14547410477242FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477273FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477303FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04961333356478PENTAX MedicalHOYA CORPORATIONFDF2025-04-28
04961333129430PENTAXHOYA CORPORATIONFDF2025-04-04
04961333172085PENTAXHOYA CORPORATIONFDF2025-04-04
84953170463910BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007041GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04953170465970EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FDF2024-11-25
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301117REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301124REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301179REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301186REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301193REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301209REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
04961333254781PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254460PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254811PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254477PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254798PENTAXHOYA CORPORATIONFDF2024-07-26
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
50724995228939DEFENDOMEDIVATORS INC.FDF2024-01-18