FDA.reportPublic FDA data

Medline

Primary DI
10884389181911
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPHUA10SG
Catalog number
MPHUA10SG
Device description
STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT
Published
2022-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389181912PackageGS124In Commercial Distribution
10884389181911PrimaryGS10
80884389181910Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438918191240884389181912
1088438918191110884389181911
8088438918191080884389181910

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389177686MEDLINEMDSMPHS4MDSMPHS42021-04-23
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CDM2025-09-18
00850054026729QMedix™Diagnostic Automation, Inc.CDM2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSCDM2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-04
08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.CDM2023-06-08
00613647008850FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CDM2022-11-29
20613647008854FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CDM2022-11-29
10884389181973MedlineMEDLINE INDUSTRIES, INC.CDM2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.CDM2021-09-16
00192024029317Ricca Chemical Company®Ricca Chemical Company, LLCCDM2021-02-04
00192024029324Ricca Chemical Company®Ricca Chemical Company, LLCCDM2021-02-04
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.CDM2020-09-30
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDCDM2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.CDM2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCCDM2020-07-09
20885380175555CARDINAL HEALTHCardinal Health 200, LLCCDM2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCCDM2020-06-30
50885380175570CARDINAL HEALTHCardinal Health 200, LLCCDM2020-06-30
08806141302070CYBOW 10DFI CO.,LTDCDM2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSCDM2020-03-09