FDA.reportPublic FDA data

Cap chain

Primary DI
04953170151767
Brand
Cap chain
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1193
Catalog number
GL2613
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
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
ODBendoscopic contamination prevention sheath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1
ODBEndoscopic Contamination Prevention SheathGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060475000EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8Olympus Medical Systems Corporation2006-03-17ODB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170151767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170151767049531701517674953170151767

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic device sterilization/disinfection tubing setA collection of devices, or a preassembled device, intended to allow connection between the appropriate port(s) of a sterilizer/disinfector and the channels, ports or distal end of an endoscope or endoscopic device (e.g., ultrasound transducer) during device sterilization and/or disinfection. It typically includes appropriate tubing, adaptors, and connectors to allow the appropriate fluids (sterilant or disinfectant) and gases to flow through the device, and might include a flow management unit. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
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
04953170437984HALOGEN LAMPMAJ-525N61756012023-04-22
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170452932TRACHEAL INTUBATION FIBERSCOPEOLYMPUS LF-PN44475402022-12-23
04953170437571CONNECTING TUBEMAJ-1503N26450012023-04-22
04953170437588CONNECTING TUBEMAJ-1504N26451012023-04-22
04953170437595CONNECTING TUBEMAJ-1505N26452012023-04-22
04953170437601CONNECTING TUBEMAJ-1508N26453012023-04-22
04953170437625CONNECTING TUBEMAJ-1511N26455012023-04-22
04953170437632CONNECTING TUBEMAJ-1512N26456012023-04-22
04953170437649CONNECTING TUBEMAJ-1513N26457012023-04-22
04953170437656CONNECTING TUBEMAJ-1514N26458012023-04-22
04953170437663CONNECTING TUBEMAJ-1515N26459012023-04-22
04953170437670CONNECTING TUBEMAJ-1516N26460012023-04-22
04953170437687CONNECTING TUBEMAJ-1517N26461012023-04-22
04953170437694CONNECTING TUBEMAJ-1764N30610012023-04-22
04953170437700WATER RESISTANT CAPMD-252N36269012023-04-22
04953170437748Water-resistant capMH-553N36274012023-04-22
04953170438318RETAINING RACKMAJ-840N61790012023-04-22
04953170438325CONNECTOR HANGERMAJ-865N61791012023-04-22
04953170434662ENDOEYE FLEX DEFLECTABLE VIDEOSCOPEOLYMPUS LTF-S190-10N38281332023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995356699CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356705CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
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
04547410564112FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957804Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957811Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957828Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
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
04897106957071Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
00850025860857CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
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