FDA.reportPublic FDA data

Urine specimen collection kit IVD

Definition
A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.
GUDID devices
505
Last updated
2026-10-06 03:49:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10885380213908Aero-MedAERO-MED, LLCCA52100A2026-09-25
10885380199165Aero-MedAERO-MED, LLCCA520752024-01-31
00850024881242LetsGetChecked Urine Sample Collection Kit (BS03)PRIVAPATH DIAGNOSTICS LIMITEDUO301, UO02S2022-03-30
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)PRIVAPATH DIAGNOSTICS LIMITEDUO01S2022-03-30
10885380193538Aero-MedAERO-MED, LLCCA442252022-08-10
10885380193675Aero-MedAERO-MED, LLCCA437752022-09-09
10885380194726Aero-MedAERO-MED, LLCCA480752023-03-09
10885380197390Aero-MedAERO-MED, LLCCA527002023-09-18
10885380199035Aero-MedAERO-MED, LLCCA485252024-01-10
10885380199042Aero-MedAERO-MED, LLCCA485502024-01-10
10885380199172Aero-MedAERO-MED, LLCCA521002024-01-31
10885380203664Aero-MedAERO-MED, LLCCA543752024-08-01
10885380208928Aero-MedAERO-MED, LLCCA50100A2025-08-21
10885380208935Aero-MedAERO-MED, LLCCA580002025-11-04
10885380211188Aero-MedAERO-MED, LLCCA44675A2026-02-13
50885380126091CARDINAL HEALTHCardinal Health 200, LLCCH3050-192026-06-10
50885380126107CARDINAL HEALTHCardinal Health 200, LLCCH3050-202026-06-10
00613647003596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.143772512022-12-07
00613647003701FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.14-375-2382022-12-07
00613647003718FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.14-375-2462022-12-07
00613647009260FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.3856LPL-FH2022-11-29
00647679162976Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc6063.22021-12-03
00647679162983Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc6062.22021-12-03
00650415208654Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company2022A x2+st2021-12-03
00650415209057Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc60652021-10-15
00653078997583Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc05.22021-12-03
00653078997590Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc10.22021-12-03
00653078997606Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc20.22021-12-03
00667605027643Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company2022Ax4+pqg2021-12-03
00801741188879SureStep Vacutainer Urine Sampling KitC. R. Bard, Inc.SSV0202020-09-03
00801741188886SureStep Vacutainer Urine Sampling KitC. R. Bard, Inc.SSV020H2020-09-03
00810010892218Aero-MedAERO-MED, LLCAMM9302019-06-27
00810010892270Aero-MedAERO-MED, LLCAMM9972019-09-23
00810010892751Aero-MedAERO-MED, LLCAMM5182020-04-24
00810010894519Aero-MedAERO-MED, LLCAMM178752024-06-12
00810077210383Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc102021-04-15
00810077210390Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc202021-04-15
00810077210406Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc1002021-04-15
00810077210413Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc60632021-04-15
00810077210420Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvk150nssc2021-04-15
00810077211052Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySTSC X052021-10-15
00810077211069Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySTSC X102021-10-15
00810077211502Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc032021-10-15
00810077211847Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanynsscX32021-10-15
00810077211908Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companynssc3.5OzX242021-10-15
00810077212066Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc60512022-03-05
00810077212110Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvk05io2021-10-15
00810077212561Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyTESC x42022-03-05
00810077212578Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyTESC x102022-03-05
00810077212592Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySPAN x202022-03-05
00810077212745Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companynssc x 52022-03-05
00810077212837Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company1580 X2 WMP2022-03-05
00810077213148Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySPAN x1002022-03-05
00810077213438Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySc3.5 x 252022-03-05
00810077213445Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySc3.5 x 502022-03-05
00810077213452Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySc3.5 x 1002022-03-05
00810077213469Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanySc3.5 x 5002022-03-05
00810077213902Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc5002022-07-29
00810077213919Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc10002022-07-29
00810077217764Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company35VKSSC2023-01-04
00810077218396Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company3VKSSC2023-01-04
00810077218402Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company8VKSSC2023-01-04
00810077218419Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company15VKSSC2023-01-04
00810077218426Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company200VKSSC2023-01-04
00810077218433Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company600VKSSC2023-01-04
00810077218440Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Company1200VKSSC2023-01-04
00850017881150RecopadMedfire Innovations Inc.Small Adult2021-05-20
00850017881174RecopadMedfire Innovations Inc.Medium Adult2021-05-20
00850017881198RecopadMedfire Innovations Inc.Large Adult2021-05-20
00850025452489Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companyvkssc052021-02-18
00850025452601Avaline Medical NJ LLCAvaline Medical NJ Limited Liability Companymc60622021-02-18
00850037921683American Hospital SupplyAmerican Hospital Supply LLCAHS-SC-S4_PK2023-02-17
00850037921690American Hospital SupplyAmerican Hospital Supply LLCAHS-SC-S4_CS2023-02-17
05060423410911Non-sterile specimen mailer and storage container PE 50 StandardBODDINGTONS PLASTICS LIMITEDPE50 Standard2023-05-25
05060423410959Peezy Non-sterile specimen mailer and storage container PE 51 BoricBODDINGTONS PLASTICS LIMITEDPE 51 Boric2023-05-09
06975679490251Sample Processing kits for Urine/Fecal AnalysisHunan Ehome Health Technology Co., Ltd.YH-HC5102025-10-10
10080196032044MedlineMEDLINE INDUSTRIES, INC.DYND302282021-10-29
10080196032068MedlineMEDLINE INDUSTRIES, INC.DYND302402021-11-05
10192253061093Aero-MedAERO-MED, LLCCA394502026-02-20
10192253061482Aero-MedAERO-MED, LLCCA414252026-02-20