FDA.reportPublic FDA data

Disposable Biopsy Valve

Primary DI
26970401814057
Brand
Disposable Biopsy Valve
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MDBV1A0000A
Catalog number
000522
Device description
ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes
Published
2019-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173758000Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.2018-05-14OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401814043PackageGS1100In Commercial Distribution
26970401814057PackageGS1500In Commercial Distribution
06970401812387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181404316970401814043
2697040181405726970401814057
06970401812387069704018123876970401812387

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, sterileA sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936534300030Disposable Ureteral StentsMD-C-JC-5F-282026-09-20
06936534300054Disposable Ureteral StentsMD-C-JC-6F-282026-09-20
06936534306070Disposable Ureteral StentsMD-C-JC-4F-142026-09-20
06936534306087Disposable Ureteral StentsMD-C-JC-4.5F-142026-09-20
06936534306094Disposable Ureteral StentsMD-C-JC-4.5F-152026-09-20
06936534306100Disposable Ureteral StentsMD-C-JC-4.5F-162026-09-20
06936534306117Disposable Ureteral StentsMD-C-JC-4.5F-182026-09-20
06936534306124Disposable Ureteral StentsMD-C-JC-4.5F-202026-09-20
06936534306131Disposable Ureteral StentsMD-C-JC-4.5F-222026-09-20
06936534306148Disposable Ureteral StentsMD-C-JC-4.5F-242026-09-20
06936534306155Disposable Ureteral StentsMD-C-JC-4.5F-262026-09-20
06936534306162Disposable Ureteral StentsMD-C-JC-4.5F-282026-09-20
06936534306179Disposable Ureteral StentsMD-C-JC-4.7F-142026-09-20
06936534306186Disposable Ureteral StentsMD-C-JC-4.7F-152026-09-20
06936534306193Disposable Ureteral StentsMD-C-JC-4.7F-162026-09-20
06936534306209Disposable Ureteral StentsMD-C-JC-4.7F-182026-09-20
06936534306216Disposable Ureteral StentsMD-C-JC-4.7F-202026-09-20
06936534306223Disposable Ureteral StentsMD-C-JC-4.7F-222026-09-20
06936534306230Disposable Ureteral StentsMD-C-JC-4.7F-242026-09-20
06936534306247Disposable Ureteral StentsMD-C-JC-4.7F-262026-09-20

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00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
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