FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489148237
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYND364981
Catalog number
DYND364981
Device description
KIT, URINE,10ML VACU TUBE, PAC
Published
2024-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489148234PackageGS150In Commercial Distribution
10193489148237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348914823420193489148234
1019348914823710193489148237

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.Protect from freezing, avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817518026275MarketLab, Inc.MARKETLAB INC.NNI2026-07-16
07333066021812EliA Stool Extraction Kit plusPhadia ABNNI2026-06-25
00827989008106Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-10
00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
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10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
00840117337374LabChoice Pet Cell Bottle, 500 mLDynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mLDynarex CorporationNNI2025-06-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28