FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410331530
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
SB-500/G
Device description
This product is the suction button used in combination with our endoscope in medical facilities.
Published
2018-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFYAdaptor, bulbs, miscellaneous, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24547410331534PackageGS11In Commercial Distribution
04547410331530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2454741033153424547410331534
04547410331530045474103315304547410331530

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. 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
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
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
true
Serial number
false
Manufacturing date on label
false
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 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995356699CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356705CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957798Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957801Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957818Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957825Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
16009900408313PeditrolWISMED PL SP Z O OFFY2025-03-17
06009900408330Smart BulbWISMED PL SP Z O OFFY2025-03-17
06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17
04547410516258FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04547410522143FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04049197151641RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
04049197522496RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
10810929044507AIR/WATER CLEANING VALVESRuhof CorporationFFY2024-10-15
00690521011526NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521011533NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020672NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020689NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
04049197461054RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197461061RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522465RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522472RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522489RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04055207019443E-LINERichard Wolf GmbHFFY2024-08-07