FDA.reportPublic FDA data

Dukal

Primary DI
00665973010175
Brand
Dukal
Company
Dukal LLC
Model
878
Catalog number
878
Device description
DK Lube Jelly 5gm Pack, ST
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10665973010172PackageGS1150In Commercial Distribution
20665973010179PackageGS110In Commercial Distribution
00665973010175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066597301017210665973010172
2066597301017920665973010179
00665973010175006659730101756659730101750665973010175

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.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973027347Dukal27602276022022-12-06
10665973032198RENCURARCCA66RCCA662024-11-04
10665973032259RENCURARCCS48RCCS482024-11-04
10665973029488UnipackUGC-6600-LUGC-6600-L2022-12-06
10665973029495UnipackUGC-6600-MUGC-6600-M2022-12-06
10665973029501UnipackUGC-6600-SUGC-6600-S2022-12-06
10665973029518UnipackUGC-6600-XLUGC-6600-XL2022-12-06
10665973029525UnipackUGC-6600-XXLUGC-6600-XXL2022-12-06
10665973029532UnipackUGC-6601-LUGC-6601-L2022-12-06
10665973029549UnipackUGC-6601-MUGC-6601-M2022-12-06
10665973029556UnipackUGC-6601-SUGC-6601-S2022-12-06
10665973029563UnipackUGC-6601-XLUGC-6601-XL2022-12-06
10665973029570UnipackUGC-6601-XXLUGC-6601-XXL2022-12-06
10665973029587UnipackUGC-6602-LUGC-6602-L2022-12-06
10665973029594UnipackUGC-6602-MUGC-6602-M2022-12-06
10665973029600UnipackUGC-6602-SUGC-6602-S2022-12-06
10665973029617UnipackUGC-6602-XLUGC-6602-XL2022-12-06
10665973029624UnipackUGC-6602-XXLUGC-6602-XXL2022-12-06
10665973029631UnipackUGC-6603-LUGC-6603-L2022-12-06
10665973029648UnipackUGC-6603-MUGC-6603-M2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16