FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410331752
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
LMP-SD
Device description
This product is the lamp unit used in combination with our light source in medical facilities.Do not use this product for any other purpose.
Published
2022-10-07
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
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
04547410331752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410331752045474103317524547410331752

GMDN Terms#

Term, Definition table
TermDefinition
Procedural cold light bulbAn electrically-powered device in the form of a light bulb designed to be integrated into an appropriate light source unit (not included) to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during surgery, examination, and/or endoscopy. It is a replaceable component of the assembly and does not include a light switch.

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 Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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Primary DI, Brand, Company table
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00724995356699CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356705CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
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00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
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04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957743andorate® Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-11-21
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04897106957828Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
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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
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14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
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06009900408316PeditrolWISMED PL SP Z O OFFY2025-03-17
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