FDA.reportPublic FDA data

Leakbuster

Primary DI
00840165400808
Brand
Leakbuster
Company
Pretium Canada Packaging ULC
Model
B1202-1O
Device description
Specimen Container, 120 ml, Orange Cap, Sterile.
Published
2025-02-21
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
00840165400815PackageGS14In Commercial Distribution
00840165400808PrimaryGS10
10840165400805Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165400815008401654008158401654008150840165400815
00840165400808008401654008088401654008080840165400808
1084016540080510840165400805

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
246665038
Device count
75
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840165401560Pinworm CollectorV302-PIN2025-10-07
10840165401185LeakbusterB602-1YN2025-04-29
10840165401406LeakbusterB602-1YNL2025-04-29
00840165400860StarplexV102-CA2025-04-29
10840165400867StarplexV102-CA2025-04-29
00840165401195LeakbusterB602-1YN2025-04-29
00840165401416LeakbusterB602-1YNL2025-04-29
10840165400966Starplex V302-F2025-03-04
10840165401062HistoplexH602-FL2025-03-04
00840165400976Starplex V302-F2025-03-04
00840165401072HistoplexH602-FL2025-03-04
00840165400266Starswab II Bacteriology Culture Collection and Transport SystemSP132-W2025-02-21
00840165400280Starswab II Bacteriology Culture Collection and Transport SystemSP132-FL2025-02-21
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemSP130L2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemSP130L-D2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemSP130L-W2025-02-21
00840165400365Starswab Dry SwabS092025-02-21
00840165400389Starswab Dry SwabS09D2025-02-21
00840165400402Starswab Anaerobic Transport SystemS120-02025-02-21
00840165400426Starswab Anaerobic Transport SystemS120-D2025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
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