FDA.reportPublic FDA data

MAINTENANCE UNIT

Primary DI
04953170060427
Brand
MAINTENANCE UNIT
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MU-1
Device description
"""MU-1 MAINTENANCE UNIT - NO CONTAINERS"""
Published
2016-09-21
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
FDFColonoscope and accessories, flexible/rigid
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051645000EVIS EXERA 160A SYSTEMOlympus Medical Systems Corporation2005-10-13NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170060427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170060427049531700604274953170060427

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope leak tester, electricalA mains electricity (AC-powered) instrument designed to test a flexible endoscope for leaks from its internal channels. It is connected to the endoscope using tubing with appropriate connectors to irrigate the channels of the endoscope with air and/or water/alcohol. This process is used for early detection of pinhole leaks to minimize the incidence of water leak damage and costly repair, especially for videoendoscopes. It is typically used by a healthcare provider (i.e., clinical technician) involved in the repair, servicing, and maintenance of flexible endoscopes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973786293260Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293284Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293307Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293321Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
04547410566253FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410477245FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477276FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477306FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
00850458007157GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
00850458007164GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
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