FDA.reportPublic FDA data

Basic Bedside Kit

Primary DI
06936603230886
Brand
Basic Bedside Kit
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-IPK-H
Catalog number
SEN-BK-3
Device description
Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning brush
Published
2025-06-23
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
NWUEndoscope Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603230883PackageGS120In Commercial Distribution
06936603230886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323088316936603230883
06936603230886069366032308866936603230886

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning sponge/setA hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
544375774
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
06936603211571Disposable Polypectomy SnareFTL-PS-24-230-30-M-NSMO-E24-6-12-30-2302026-10-25
06936603211588Disposable Polypectomy SnareFTL-PS-24-230-30-ACM-NSMO-EA24-6-12-30-2302026-10-25
06936603211595Disposable Polypectomy SnareFTL-PS-24-230-30-M-RSMO-24-6-12-30-2302026-10-25
06936603211618Disposable Polypectomy SnareFTL-PS-24-230-30-MT-RSMO-T24-6-12-30-2302026-10-25
06936603211663Disposable Polypectomy SnareFTL-PS-24-230-10-O-RSOV-DR-24-10-2302026-10-25
06936603211670Disposable Polypectomy SnareFTL-PS-24-230-15-O-RSOV-DR-24-15-2302026-10-25
06936603211687Disposable Polypectomy SnareFTL-PS-24-230-20-O-RSOV-DR-24-20-2302026-10-25
06936603211694Disposable Polypectomy SnareFTL-PS-24-230-25-O-RSOV-DR-24-25-2302026-10-25
06936603211700Disposable Polypectomy SnareFTL-PS-24-230-30-O-RSOV-DR-24-30-2302026-10-25
06936603211731Disposable Polypectomy SnareFTL-PS-24-230-15-O-NSOV-DS-23-15-2302026-10-25
06936603211748Disposable Polypectomy SnareFTL-PS-24-230-20-O-NSOV-DS-23-20-2302026-10-25
06936603211755Disposable Polypectomy SnareFTL-PS-24-230-25-O-NSOV-DS-23-25-2302026-10-25
06936603211779Disposable Polypectomy SnareFTL-PS-24-230-35-O-NSOV-DS-23-35-2302026-10-25
06936603216187Kirei FlowFTL-VS-O-HVS-KIT-07-OLY2026-10-25
06936603218259CO2 AdapterFTL-EFC-O-COAD-CO2-OUS2026-10-25
06936603235508CO2 AdapterFTL-EFC-O-CORAD-CO2-OUS-R2026-10-25
06936603211625Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-RCPS-CR-24-02-10-2302026-10-22
06936603211649Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-NCPS-CS-24-02-10-2302026-10-22
06936603211724Disposable Polypectomy SnareFTL-PS-24-230-10-O-NSOV-DS-23-10-2302026-10-22
06936603211908Disposable Biopsy ForcepsFTL-BF-18-180-O-O-RTC11-ECO-S-18-180-SU2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956506572CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
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10198956615397CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
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06936603237410GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237427GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237434GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237441GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
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06936603237465GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
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06936603237496GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237502GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
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10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
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10198956612648CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
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10198956565388CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15