FDA.reportPublic FDA data

BioShield

Primary DI
00724995199258
Brand
BioShield
Company
US Endoscopy
Model
00711903
Catalog number
00711903
Device description
The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channel of flexible gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
Published
2021-09-15
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
ODDEndoscopic retrograde cholangiopancreatography (ERCP) cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) CannulaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202583000BioShield biopsy valve EUS - LinearSTERIS Corporation2020-11-06ODD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995199255PackageGS125In Commercial Distribution
00724995199258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499519925510724995199255
00724995199258007249951992587249951992580724995199258

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
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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
04953170466045Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466052Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466069Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466076Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466083Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466090Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466106Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466113Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466120Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466042Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466059Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466066Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466073Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466080Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466097Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466103Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466110Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466127Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
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