FDA.reportPublic FDA data

BioShield

Primary DI
00724995183523
Brand
BioShield
Company
US Endoscopy
Model
00711128
Catalog number
00711128
Device description
The BioShield biopsy valve - sterile is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
Published
2020-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCXendoscopic irrigation/suction system
ODCEndoscope channel accessory
ODDEndoscopic retrograde cholangiopancreatography (ERCP) cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) CannulaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070420000
K210342000
K232951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070420000BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.2007-03-19ODD
K210342000BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating AdaptorSTERIS Corporation2021-09-03ODC
K232951000BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)Steris2023-10-20ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995183520PackageGS1100In Commercial Distribution
00816765011072PreviousGS10
00724995183523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518352010724995183520
00816765011072008167650110728167650110720816765011072
00724995183523007249951835237249951835230724995183523

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel valve, single-useA device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
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
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
00191506040208AutoCap™ RXBOSTON SCIENTIFIC CORPORATIONODC2024-04-23
40677964030985ENDOGATORMEDIVATORS INC.OCX2024-02-29
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.OCX2024-01-22
40677964011212Endogator Hybrid Irrigation TubingMEDIVATORS INC.OCX2023-08-31
00677964059643ENDOGATOR KitMEDIVATORS INC.OCX2023-08-31
00677964094705Defendo Single Use Valve KitMEDIVATORS INC.ODC2023-06-20
50603468008998CS-05-00-290 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
50603468009056CS-05-30-290 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
50603468009124CS-05-00-300 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
50603468009292CS-05-30-300 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
50603468009360CS-05-00-315 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
50603468009438CS-05-30-315 OpClear DisposableCIPHER SURGICAL LIMITEDOCX2022-12-22
40677964031609ENDOGATORMEDIVATORS INC.OCX2022-07-29