FDA.report

Leakbuster

Primary DI
00840165500430
Company
Starplex Scientific Corp.
Model
B902-1WNLTS
Device description
Specimen Container, 90 ml, White Cap, No Label, 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

Related Records

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00840165500430PackageGS14In Commercial Distribution
10840165500420PrimaryGS10
00840165500423Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840165500430PackageGS1410840165500420In Commercial Distribution
10840165500420PrimaryGS10
00840165500423Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNIContainer, Specimen, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840165500218HistoplexH1202-FL2025-05-30
00840165500300Leakbuster 3TW952-O2025-05-28
00840165500324Leakbuster 3TW902-O-OR2025-05-28
00840165500362LeakbusterB1202-1W-OR2025-05-28
00840165500485LeakbusterB1252-1O2025-05-28
00840165500508LeakbusterB1202-1O-OR2025-05-28
00840165500058LeakbusterWB902-1O2025-05-28
00840165500072StarCLICK 100B1002-OCC2025-05-28
00840165500096StarCLICK 100B1002-YCC2025-05-28
00840165500119LeakbusterB902-1YN2025-05-28
00840165500133LeakbusterWB902-1YN2025-05-28
00840165500157LeakbusterB1202-1YN2025-05-28
00840165500171LeakbusterWB902-1ONTS2025-05-28
00840165500195HistoplexH902-FL2025-05-28
00840165500294Leakbuster 3TW902-O2025-05-28
00840165500355LeakbusterB902-1W2025-05-28
00840165500393LeakbusterB902-1OTS2025-05-28
00840165500416LeakbusterB902-1YNTS2025-05-28
00840165500454LeakbusterWB902-1OTS2025-05-28
00840165500478LeakbusterWB902-1WTSS2025-05-28

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00840117337381LabChoice Pet Cell Bottle, 1000 mL Dynarex CorporationNNI2025-06-16
00840165500218HistoplexStarplex Scientific Corp.NNI2025-05-30
00840165500096StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
00840165500119LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500133LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500157LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500171LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500195HistoplexStarplex Scientific Corp.NNI2025-05-28
00840165500416LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165401195LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840165401416LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840117336414LabChoice 24-Hour Urine Collection Container, 3000 mL Dynarex CorporationNNI2025-04-17
10827989003214Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-04-15
00810180841689LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MILDynarex CorporationNNI2025-04-07
00810180841672LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL Dynarex CorporationNNI2025-04-07
29120126131459VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00810180841665LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-SterileDynarex CorporationNNI2025-03-28
00810180841658LabChoice Specimen Bags, 12" x 15", 1.8 milDynarex CorporationNNI2025-03-28
10827989003221Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-03-13
00810180841467LabChoice Specimen Containers, 60 mL, Non-SterileDynarex CorporationNNI2025-03-11
00810180841474LabChoice Specimen Containers, 100 mL, NonSterileDynarex CorporationNNI2025-03-11
00810180841450LabChoice Specimen Containers, 40 mL, Non-SterileDynarex CorporationNNI2025-03-11
00860009784895Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
00840165400976Starplex Pretium Canada Packaging ULCNNI2025-03-04
00850025860017ESD Specimen TrayMicro-tech UsaNNI2025-02-28
04250306301219SalivaGene CollectorInvitek Molecular GmbHNNI2025-02-12
20197344020765MEDLINEMEDLINE INDUSTRIES, INC.NNI2024-11-22