FDA.reportPublic FDA data

GI Procedure Kit

Primary DI
06936603235195
Brand
GI Procedure Kit
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-BCS-S1-BZ-W
Catalog number
BCS-ENZ-SET
Device description
Endoscope cleaning sponge kit: S1 cylindrical sponge, 6 mL 3E Cleaner enzymatic detergent and 850 mL basin
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603235192PackageGS116In Commercial Distribution
26936603235199PackageGS14In Commercial Distribution
06936603235195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323519216936603235192
2693660323519926936603235199
06936603235195069366032351956936603235195

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
DM exempt
false
Premarket exempt
true
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
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
06936603211953Disposable Biopsy ForcepsFTL-BF-30-230-O-O-RTC11-ECO-30-230-SU2026-10-22
06936603211977Disposable Biopsy ForcepsFTL-BF-23-180-O-O-RTC11-SJ-23-180-SU2026-10-22
06936603212059Disposable Biopsy ForcepsFTL-BF-18-180-W-O-RTC12-ECO-S-18-180-SU2026-10-22
06936603212103Disposable Biopsy ForcepsFTL-BF-30-230-W-O-RTC12-ECO-30-230-SU2026-10-22
06936603212196ECO InjectFTL-IN-24-230-22-4IHN-23-22-4-2302026-10-22
06936603212202ECO InjectFTL-IN-24-230-22-5IHN-23-22-5-2302026-10-22
06936603212219ECO InjectFTL-IN-24-230-22-6IHN-23-22-6-2302026-10-22
06936603212240ECO InjectFTL-IN-24-230-23-4IHN-23-23-4-2302026-10-22
06936603212257ECO InjectFTL-IN-24-230-23-5IHN-23-23-5-2302026-10-22
06936603212271ECO InjectFTL-IN-24-230-25-5IHN-23-25-5-2302026-10-22
06936603212288ECO InjectFTL-IN-24-230-25-4IHN-23-25-4-2302026-10-22
06936603212295ECO InjectFTL-IN-24-230-25-6IHN-23-25-6-2302026-10-22
06936603212301Clean Connecting TubeFTL-EFC-IT-ETSIT-ETS-2102026-10-22
06936603212318Clean Connecting TubeFTL-EFC-IT-STD-FSIT-OUS-2102026-10-22
06936603212424Clean Connecting TubeFTL-EFC-O-H2-B1WBUC-HYB-OL42026-10-22
06936603212448Clean Connecting TubeFTL-EFC-O-S-B1WBUC-OL2-NC22026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640141627150NABelimed AGFLG2026-10-20
07640141627167NABelimed AGFLG2026-10-20
07640141627174NABelimed AGFLG2026-10-20
07640141627181NABelimed AGFLG2026-10-20
07640141627198NABelimed AGFLG2026-10-20
07640141627204NABelimed AGFLG2026-10-20
17640141627157NABelimed AGFLG2026-10-20
00840456222515JMUJMU DENTAL, INCFLG2026-07-20
10724995218864PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218848PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218855PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
00724995231057ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231064ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231071ProlysticaSTERIS CORPORATIONFLG2026-01-14
10705037018062ENZOL™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018130CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018161CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
D661UC300230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
H816GEL121Spec Clean Pre Treatment GelMicroCare, LLCFLG2025-10-23
H816OP1281OptizymeMicroCare, LLCFLG2025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsMicroCare, LLCFLG2025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalineMicroCare, LLCFLG2025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PLR32Spec Clean Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22