FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410520545
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EB-710XT
Device description
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.
Published
2024-05-15
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
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240075000FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation2024-02-07EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547410520542PackageGS11In Commercial Distribution
04547410520545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741052054214547410520542
04547410520545045474105205454547410520545

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, reusableAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. 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"", ""Hydrogen Peroxide""]"

Contacts#

Phone, Email table
PhoneEmail
+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
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
04573596200704APERTO LucentAPERTO LucentAPERTO Lucent2024-09-19
04547410334494Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B15-2016-09-16
04547410334500Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B20-2016-09-16
04547410334517Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B25-2016-09-16
04547410334524Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B30-2016-09-16
04547410334531Fujifilm Diathermic Slitter (FlushKnife)DK2618J -N10-2016-09-16

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