FDA.reportPublic FDA data

Endoclean

Primary DI
06973141950043
Brand
Endoclean
Company
Changzhou Endoclean Medical Device Co.,Ltd
Model
EDKN-004002/004006/004007/004008
Published
2025-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MNKEndoscopic Bite Block
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973141950043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973141950043069731419500436973141950043

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
705006876
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973141950845EndocleanEDKN-004005/004006/004013/004014/0040192026-07-16
06973141950173EndocleanEDKN-0020012026-04-29
06973141950319EndocleanEDKN-004005/004006/004013/0040142026-04-29
06973141950302EndocleanEDKN-004006/004013/0040142026-04-28
00697314195036EndocleanEDKN-004006/004007/0040082025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603216187Kirei FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-25
06936603216200Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216224Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216231Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216248Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216262Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603234938Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
06936603235140Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
06936603235157Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
06936603235164Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
00850025860970Endoscopy Kit - Basic Aux HBMicro-tech UsaODC2026-10-12
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONODC2026-08-25
06973141950845EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2026-07-16
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
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
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
00724995247300NAMEDIVATORS INC.ODC2026-03-02