FDA.reportPublic FDA data

Basic Bedside Kit

Primary DI
06936603230879
Brand
Basic Bedside Kit
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-IPK-G
Catalog number
SEN-BK-2
Device description
Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker
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
16936603230876PackageGS120In Commercial Distribution
06936603230879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323087616936603230876
06936603230879069366032308796936603230879

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
06936603230978Cleaning SpongeFTL-BCS-S1-BZSEN-3ECS2025-06-23
06936603225707Basic Bedside KitFTL-IPK-AM2BBK-12024-02-26
06936603225691Disposable Cleaning BrushFTL-CB-V12-IVB-12024-01-30
06936603227718HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
16936603227715HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
06936603228937Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
06936603231739Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
16936603228934Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
06936603226902Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
16936603226909Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
06936603210567Disposable Endoscopy Valve SetFTL-VS-PI20-A1152822024-03-08
06936603216460Disposable Endoscopy Adapter SetsFTL-VS-P-A1152922024-03-08
06936603216477Disposable Endoscopy Adapter SetsFTL-VS-P-B11152932024-03-08
06936603216491Disposable Endoscopy Adapter SetsFTL-VS-P-K11152942024-03-08
06936603224403Disposable Endoscopy Valve SetFTL-VS-PI20-B1152832024-03-08
06936603224410Disposable Endoscopy Valve SetFTL-VS-PI20-C1152842024-03-08
06936603227947Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
16936603227944Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
06936603230862Bedside Cleaning SpongeFTL-BCS-S1-BZ-WSEN-BK-12025-06-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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