FDA.reportPublic FDA data

Starplex

Primary DI
00840165400860
Brand
Starplex
Company
Pretium Canada Packaging ULC
Model
V102-CA
Device description
10 ml Urine Preservative Vial, for Urine Culture and Urinalysis, Sterile
Published
2025-04-29
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
00840165400860PrimaryGS10
10840165400867Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165400860008401654008608401654008600840165400860
1084016540086710840165400867

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated urine specimen container IVD, preservativeA covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, preservation, and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. It may include a disposable pipette to transfer the urine specimen into a secondary container (not included). This is a single-use device.

Regulatory Flags#

DUNS number
246665038
Device count
500
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
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
00840165400440Starswab Anaerobic Transport SystemS120-52025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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