FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410079197
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
CA-500B
Device description
This product is the cleaning adapter used in combination with our endoscopes in medical facilities.Do not use this product for any other purpose.
Published
2016-10-18
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)
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410331387PackageGS11In Commercial Distribution
04547410079197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410331387045474103313874547410331387
04547410079197045474100791974547410079197

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, reusableAn endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. 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 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 table
Method
"[""Ethylene Oxide"", ""High-level Disinfectant""]"
Ethylene Oxide;High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410582901FDR CROSS SlimDR-XD 3000 SLIM MBL E2026-08-14
04547410524642FUJIFILMEB-840T2026-07-30
04547410524680FUJIFILMEB-840S2026-07-30
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212325S3ESELS3ESEL2021-07-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211953Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211977Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212059Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212103Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224878Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224885Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224892Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224915Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224939Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603230817Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06975339628871Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-10-19
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027298ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027304ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027311ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027328ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027335ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027342ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027557ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027564ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027571ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027588ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027595ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027601ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027618ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027625ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30