FDA.reportPublic FDA data

Adapter Set for Olympus EUS Linear

Primary DI
00843356101195
Brand
Adapter Set for Olympus EUS Linear
Company
CYGNUS MEDICAL L.L.C.
Model
ASO5E
Device description
Adapter Set for Olympus EUS Linear(1) AIR WATER/SUCTION FLOW(1) SUCTION PLUG(1) LL-MALE CAP - Non-Vented Male Luer Lock Cap, Recessed Stem, Light Blue (1) TS-M4.7-20MM-WH-STANDOFF ETTINGER PART NUMBER: 05.34.200FEMALE TO FEMALE 20MM STANDOFF, M4 THREAD, NATURAL/WHITE COLOR, GLASS FIBER REINFORCED NYLON -1 Set / 100 Sets per Case
Published
2023-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JRJUnit, Drying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRJUnit, DryingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843356101192PackageGS1100In Commercial Distribution
00843356101195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084335610119210843356101192
00843356101195008433561011958433561011950843356101195

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope dryerAn electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843356102932CYGNUSLTS12122026-02-16
00843356102949CYGNUSLTS12162026-02-16
00843356102956CYGNUSLTS24242026-02-16
00843356102963CYGNUSASO3E1602026-01-15
00843356102888CYGNUSASO3E1902025-12-16
00843356102895CYGNUSASO6E1602025-12-16
00843356102857CYGNUSCCL5002025-07-11
00843356102864CYGNUSSTR5002025-07-11
00843356101812Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC190R2024-12-31
00843356101829Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC270R2024-12-31
10843356102694CYGNUSGTG-A-20002024-12-11
00843356102741CYGNUSEC03082024-11-20
00843356102758CYGNUSEC0308-SI2024-11-20
00843356102765CYGNUSEC06122024-11-20
00843356102772CYGNUSEC0612-SI2024-11-20
00843356102789CYGNUSEC07132024-11-20
00843356102796CYGNUSEC0713-SI2024-11-20
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20840113298758CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-20
10840113298638CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113299482CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298642CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298765CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298772CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298796CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298802CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298819CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298895CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298901CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298994CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299007CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299014CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299021CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299052CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299083CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299090CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299106CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299120CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299151CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113298928CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
10840113298980CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298932CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298949CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298956CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298963CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298970CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113299168CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
00814707023824CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10