FDA.reportPublic FDA data

Leakbuster 3

Primary DI
00840165500317
Brand
Leakbuster 3
Company
Starplex Scientific Corp.
Model
TW952-O
Device description
Specimen Container, 90 ml, Tamper Evident Orange Cap, Individually Packaged in Peel Pack with Castile Soap Towelette, Sterile.
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165500317PrimaryGS10
00840165500300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165500317008401655003178401655003170840165500317
00840165500300008401655003008401655003000840165500300

GMDN Terms#

Term, Definition table
TermDefinition
Midstream urine specimen container IVDA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). 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
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
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
10198459319990Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-04-18
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
H1084316251CorningCorning IncorporatedFMH2024-10-29