FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410436501
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EI-740D/S
Device description
FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Published
2021-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAMSigmoidoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAMSigmoidoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210162000
K221551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210162000Endoscope Model EI-740D/SFujifilm Corporation2021-04-09FDS
K221551000FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton2023-01-27FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547410436508PackageGS11In Commercial Distribution
04547410436501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741043650814547410436508
04547410436501045474104365014547410436501

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video upper/lower gastrointestinal endoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper (e.g., oesophagus, stomach, duodenum) and lower (e.g., rectum, colon) gastrointestinal (GI) tract; it is not dedicated for use in a specific part of the GI tract. It is inserted into the body through the mouth or anus. 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#

Type, Low, High table
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 Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(800)272-8465xxx@xxx.xxx
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596201367OASISMR-NVC-120OASIS RAPID NV Coil MR-NVC-1202026-05-29
04573596201398OASISMR-QFC-120OASIS QD Flexible Body Coil(L) MR-QFC-1202026-05-29
04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
04573596202159OASISMR-IBC-120OASIS RAPID Breast Coil MR-IBC-1202026-05-29
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410566253FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410477153FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04547410532876FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04547410500646FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410528268FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850006222322Pathfinder® CR SystemNEPTUNE MEDICAL INC.FDS2024-07-09
14961333079343PENTAXHOYA CORPORATIONFDS2023-07-31
14961333085535PENTAXHOYA CORPORATIONFDS2023-07-31
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424298COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170453823DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453830DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453847DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453854DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29