FDA.reportPublic FDA data

Leakbuster

Primary DI
00840165500416
Brand
Leakbuster
Company
Starplex Scientific Corp.
Model
B902-1YNTS
Device description
Specimen Container, 90 ml, Yellow Cap, Applied Temperature Strip, Non-Sterile.
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00840165500416PackageGS14In Commercial Distribution
10840165500406PrimaryGS10
00840165500409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165500416008401655004168401655004160840165500416
1084016550040610840165500406
00840165500409008401655004098401655004090840165500409

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859771235
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10840165500727StarCLICK 100B1002-OCCTS2025-10-10
10840165500741StarCLICK 100B1002-YCCNLTS2025-10-10
10840165500765StarCLICK 100B1002-YCCTS2025-10-10
10840165500802LeakbusterB1202-1YNL2025-10-10
10840165500567LeakbusterWB902-1BNL2025-10-07
10840165500581LeakbusterWB902-1ONTSTAB2025-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
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
10840165500581LeakbusterStarplex 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
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28