FDA.reportPublic FDA data

sterile lubricating jelly / water soluble

Primary DI
06936603238042
Brand
sterile lubricating jelly / water soluble
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-LA-180-A
Catalog number
SG-018
Device description
Lubricant, sachet, 18 g
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
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603238049PackageGS120In Commercial Distribution
26936603238046PackageGS110In Commercial Distribution
06936603238042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323804916936603238049
2693660323804626936603238046
06936603238042069366032380426936603238042

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

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
00850025860970Endoscopy Kit - Basic Aux HBMicro-tech UsaKMJ2026-10-12
10801902221596ARROWTELEFLEX INCORPORATEDKMJ2026-07-29
00692379000097Water-based Lubricant for UrestaResilia IncKMJ2026-07-03
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16