FDA.reportPublic FDA data

Leakbuster

Primary DI
10840165500581
Brand
Leakbuster
Company
Starplex Scientific Corp.
Model
WB902-1ONTSTAB
Device description
Specimen Container, 90 ml Wide Mouth, Orange Cap, Applied Temperature Strip, Non-Sterile.
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165500591PackageGS14In Commercial Distribution
10840165500581PrimaryGS10
00840165500584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165500591008401655005918401655005910840165500591
1084016550058110840165500581
00840165500584008401655005848401655005840840165500584

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing urine specimen container IVDA covered plastic receptacle with a temperature strip and/or tamperproof seal intended to be used for the collection, and preservation and/or transport, of a urine specimen for drug testing and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
859771235
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840165500727StarCLICK 100B1002-OCCTS2025-10-10
10840165500741StarCLICK 100B1002-YCCNLTS2025-10-10
10840165500765StarCLICK 100B1002-YCCTS2025-10-10
10840165500802LeakbusterB1202-1YNL2025-10-10
10840165500567LeakbusterWB902-1BNL2025-10-07
10840165500604LeakbusterWB902-1WNL2025-10-07
10840165500628LeakbusterWB902-1WTS2025-10-07
10840165500642LeakbusterB1202-1ONL2025-10-07
10840165500666LeakbusterB1202-1OTS2025-10-07
10840165500680LeakbusterB902-1YNL2025-10-07
10840165500703LeakbusterB902-1WNL2025-10-07
00840165500553Starplex Specimen ContainerWB902-SO-OR2025-10-07
10840165500208HistoplexH1202-FL2025-05-30
00840165500218HistoplexH1202-FL2025-05-30
10840165500048LeakbusterWB902-1O2025-05-28
10840165500062StarCLICK 100B1002-OCC2025-05-28
10840165500086StarCLICK 100B1002-YCC2025-05-28
10840165500109LeakbusterB902-1YN2025-05-28
10840165500123LeakbusterWB902-1YN2025-05-28
10840165500147LeakbusterB1202-1YN2025-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138"LabChoice Specimen Bags, Clear, 8"" x 10"", 1.8 MIL"Dynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039"LabChoice Specimen Bags, 6"" x 9"", 1.8 MIL, Non-Sterile"Dynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
10840165400966Starplex Pretium Canada Packaging ULCNNI2025-03-04
30197344020762MEDLINEMEDLINE INDUSTRIES, INC.NNI2024-11-22
10193489148237MEDLINEMEDLINE INDUSTRIES, INC.NNI2024-07-29
10193489148244MEDLINEMEDLINE INDUSTRIES, INC.NNI2024-07-08