FDA.reportPublic FDA data

OrcaPod™

Primary DI
08714729981558
Brand
OrcaPod™
Company
BOSTON SCIENTIFIC CORPORATION
Model
SUV-628
Catalog number
SUV-628
Device description
Single Use Air/Water, Suction and Biopsy Valves Set
Published
2018-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCXendoscopic irrigation/suction system
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729981565PackageGS150In Commercial Distribution
08714729981558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729981565087147299815658714729981565
08714729981558087147299815588714729981558

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Regulatory Flags#

DUNS number
021717889
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.ODC2025-01-10
08057502310108Endorail SetENDOSTART SRLODC2024-10-16
00724995197681DEFENDOUS EndoscopyODC2024-07-15
40677964031517ENDOGATORMEDIVATORS INC.OCX2024-05-29
00724995224035EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224059EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224189EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224202EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224226EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00191506040208AutoCap™ RXBOSTON SCIENTIFIC CORPORATIONODC2024-04-23
00724995229641DEFENDOMEDIVATORS INC.ODC2024-03-25