FDA.reportPublic FDA data

Kidney Stone Transportation Kit

Primary DI
10860009616032
Brand
Kidney Stone Transportation Kit
Company
Ditek Consulting, LLC
Model
71340
Device description
Kidney Stone Transportation Kit
Published
2024-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OIEUrine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009616032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000961603210860009616032

GMDN Terms#

Term, Definition table
TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen 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 sizes, shapes, and materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111296701
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
00860013969561Specimen Collection Kit1463452025-10-13
00860011770282Kidney Stone Collection Kit1462252025-09-11
00860013969554Ditek BioBank Kit (Labcorp)1460452025-08-28
00860013969547High Altitude QuantiFERONTest Kit1217272025-06-17
10860013969544High Altitude QuantiFERONTest Kit1217272025-06-17
00860013969530NMS Umbilical Cord Kit380371G2025-06-09
00860013899264Paternity Test Kit 50469332025-05-06
00860013899288Paternity Test Kit 25926962025-05-06
10860013899261Paternity Test Kit 50469332025-05-06
00860013899271Paternity Test Kit 1968352025-05-06
10860013899285Paternity Test Kit 25926962025-05-06
00860013899295Colofit Test KitDTCF012025-05-06
00860013969509Kidney Combo Test Kit 1KHK012025-05-06
00860013969516Kidney Health Test Kit 2 eGFR012025-05-06
00860013969523Kidney Health Test Kit 3uACR012025-05-06
00860011770268Covid 19 Testing Kit1413142025-05-01
00860011770220NIPS Single Pack Testing Kit1163732025-05-01
10860011770265Covid 19 Testing Kit1413142025-05-01
10860011770203Alzheimer's Evalutation CSF Kit1408572025-05-01
20860011770231NIPS Combo Collection Kit1312612025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160518397MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OIE2026-04-07
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00382903649341BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
19120126131407VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131414VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131421VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131469VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131404VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131411VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131428VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131466VACUETTEGreiner Bio-One GmbHOIE2026-01-26
50382903649322BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
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00860013362904RTL Urine Collection KitRealtime Laboratories, Inc.OIE2025-02-28
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G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
00850054552051US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
10850054552058US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
04580455981025Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
00810113420028INDICAID health Sexual Health 2Phase Diagnostics, Inc.OIE2023-10-03
00860010959206US Biotek LaboratoriesU.S. Biotek Laboratories LLCOIE2023-09-15
00810040820625Cue Sample Collection Kit Cue Health Inc.OIE2023-02-27
00860193001761UroMap Specimen Collection KitCAREDX, INC.OIE2023-02-10