FDA.reportPublic FDA data

Kubbie 3D Specimen Manager

Primary DI
B619K0030C010
Brand
Kubbie 3D Specimen Manager
Company
Kubtec
Model
K0030C01
Device description
Kubbie 3D Specimen Manager contains 10 Specimen Containers & Lids, 10 Nodes & Shaves Trays & Lids, 10 Orientation Markers, and 10 Specimen Holder Membranes.
Published
2026-04-30
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
B619K0030C010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General specimen receptacle transport containerA non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.

Regulatory Flags#

DUNS number
361955128
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B619A90000102Kubbie Container and Nodes & Shaves TrayA90-00012026-04-27
B619A90000304Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619A90000506Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619A9000203Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619X42QK0XPERT42XPERT 422025-03-26
B619X80LAR0XPERT80LXPERT 80L2025-03-26
B619X80QT0XPERT80XPERT 802025-03-26
B619X84R3XPERT84XPERT842025-03-26
B619K0018C01UP0GammaPro Straight Standard ProbeK0018C012025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeK0019C012025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeK0020C012025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeK0021C012025-03-26
B619X20Q9XPERT20XPERT 202025-03-26
B619X40QF0XPERT40XPERT 402025-03-26
B619GPROHISKIT0GammaPro Hi-Sense Probe with Tablet and Carry Case K0019C022022-10-14
B619GPROHISPROBE0GammaPro High Sensitivity ProbeK0019C012022-10-14
B619GPROLAPKIT0GammaPro Laparoscopic Probe with Tablet and Carry CaseK0020C022022-10-14
B619GPROLAPPROBE0GammaPro Laparoscopic ProbeK0020C012022-10-14
B619GPROSTDANGPROBE0GammaPro Angled Standard ProbeK0021C012022-10-14
B619GPROSTDKIT0GammaPro Standard Probe with Tablet Carry Case K0018C022022-10-14

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Primary DI, Brand, Company table
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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
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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