FDA.reportPublic FDA data

Kubbie Specimen Membranes and Orientation Markers

Primary DI
B619A9000203
Brand
Kubbie Specimen Membranes and Orientation Markers
Company
Kubtec
Model
A90-0002
Device description
Kubbie Specimen Membranes and Orientation Markers contain 10 Specimen Holder Membranes and 10 Orientation Markers.
Published
2026-04-27
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
B619A9000203PrimaryHIBCC0

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
B619K0030C010Kubbie 3D Specimen ManagerK0030C012026-04-30
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
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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