FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
10809160518397
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
78532B
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20809160518394PackageGS120In Commercial Distribution
10809160518397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916051839420809160518394
1080916051839710809160518397

GMDN Terms#

Term, Definition table
TermDefinition
Midstream urine specimen container IVDA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07
10809160520468Medical Action Industries771202026-05-05
10809160016770Medical Action Industries718912016-08-20
10809160394052Medical Action Industries833482023-02-09
10809160435038Medical Action Industries838262024-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50382903649346BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
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
00382903649327BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00810185250547TherapakTherapak LLCOIE2025-08-11
00810185250554TherapakTherapak LLCOIE2025-08-11
00850024881846LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)PRIVAPATH DIAGNOSTICS LIMITEDOIE2025-07-07
00840117338029LabChoice Midstream Specimen Catch Kit, SterileDynarex CorporationOIE2025-03-14
00860013362904RTL Urine Collection KitRealtime Laboratories, Inc.OIE2025-02-28
G7327021Everlywell Blood and Urine Collection KitEverly Health, Inc.OIE2025-02-18
G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
10860009616032Kidney Stone Transportation KitDitek Consulting, LLCOIE2024-11-19
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