FDA.report

ADAPTER SET FOR OLYMPUS FLEXIBLE BRONCHOSCOPES

Primary DI
10843356102496
Brand
ADAPTER SET FOR OLYMPUS FLEXIBLE BRONCHOSCOPES
Company
CYGNUS MEDICAL L.L.C.
Model
ASFB1
Device description
ADAPTER SET FOR OLYMPUS FLEXIBLE BRONCHOSCOPES - 1 set
Published
2020-09-24
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
true

Related Records

Product Codes

CodeName
JRJUnit, Drying

Product Code Classifications

CodeDeviceSpecialtyClass
JRJUnit, DryingClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10843356102496PackageGS1100In Commercial Distribution
00843356102499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084335610249610843356102496
00843356102499008433561024998433561024990843356102499

GMDN Terms

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

Regulatory Flags

DUNS number
103169095
Device count
1
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company

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 Currently unpublished.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 Currently unpublished.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
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20
90843356102775CYGNUSEC0612-SI2024-11-20
90843356102782CYGNUSEC07132024-11-20
90843356102799CYGNUSEC0713-SI2024-11-20
00843356102840CYGNUSHLD250R2024-11-20
90843356102805CYGNUSTBLT-RL2024-09-11
00843356102819CYGNUSSCC152024-08-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00843356102963CYGNUSCYGNUS MEDICAL L.L.C.JRJ2026-01-15
00843356102888CYGNUSCYGNUS MEDICAL L.L.C.JRJ2025-12-16
00843356102895CYGNUSCYGNUS MEDICAL L.L.C.JRJ2025-12-16
08051520011337SteelcoSTEELCO SPAJRJ2025-07-24
00843356102864CYGNUSCYGNUS MEDICAL L.L.C.JRJ2025-07-11
08051520021022SteelcoSTEELCO SPAJRJ2025-04-22
08051520020667SteelcoSTEELCO SPAJRJ2025-03-24
08051520019623SteelcoSTEELCO SPAJRJ2025-01-14
08051520011344SteelcoSTEELCO SPAJRJ2024-11-14
08051520017360SteelcoSTEELCO SPAJRJ2024-09-11
08051520017063SteelcoSTEELCO SPAJRJ2024-05-28
00860010835203Storage CabinetWassenburg Medical, Inc.JRJ2024-04-23
00860010835234DRY320Wassenburg Medical, Inc.JRJ2024-04-23
10843356102700Air Time CYGNUS MEDICAL L.L.C.JRJ2024-02-01
08051520016042SteelcoSTEELCO SPAJRJ2024-01-29
18011517151283ENDODRYCANTEL MEDICAL (ITALY) SRLJRJ2023-11-02
G434DRY320DRY320Wassenburg Medical, Inc.JRJ2023-10-31
08051520012846SteelcoSTEELCO SPAJRJ2023-09-01
08051520012686SteelcoSTEELCO SPAJRJ2023-08-31
08051520012693SteelcoSTEELCO SPAJRJ2023-08-31
G434SC200001Storage CabinetWassenburg Medical, Inc.JRJ2023-07-27
10843356102373Air Time CYGNUS MEDICAL L.L.C.JRJ2023-06-30
18011517151269ENDODRYCANTEL MEDICAL (ITALY) SRLJRJ2023-05-15
00843356100808Adapter Set for Olympus Dual Channel EndoscopesCYGNUS MEDICAL L.L.C.JRJ2023-03-31
00843356101195Adapter Set for Olympus EUS LinearCYGNUS MEDICAL L.L.C.JRJ2023-03-03
10843356101208Adapter Set for Olympus EUS RadialCYGNUS MEDICAL L.L.C.JRJ2023-03-03
10843356101215Adapter Set for Olympus EBUS Endobronchial UltrasoundCYGNUS MEDICAL L.L.C.JRJ2023-03-03
008433561011884-Port Direct Flow Tubing SetCYGNUS MEDICAL L.L.C.JRJ2023-02-28
08051520005305SteelcoSTEELCO SPAJRJ2022-11-29
10843356101833Covers for air/water button and suction button. Biopsy port cover.CYGNUS MEDICAL L.L.C.JRJ2022-09-30