FDA.reportPublic FDA data

Dover

Primary DI
10884521000285
Brand
Dover
Company
Cardinal Health, Inc.
Model
5204
Catalog number
5204
Device description
Midstream Specimen Catch Kit,Benzalkonium Chloride Towelettes
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCNUrinary drainage collection kit, for indwelling catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521000282PackageGS148Not in Commercial Distribution
10884521000285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100028220884521000282
1088452100028510884521000285

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
10192253051629DoverCardinal Health 200, LLCFCN2025-11-07
00661392002388LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
00661392025646LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
10840330701751ProCureTwin Med, LLCFCN2025-05-31
10840330701768ProCureTwin Med, LLCFCN2025-05-31
10840330701775ProCureTwin Med, LLCFCN2025-05-31
10840330701782ProCureTwin Med, LLCFCN2025-05-31
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
00850058254791TruCathHR PHARMACEUTICALS INC.FCN2025-01-16
10192253027686DoverCardinal Health 200, LLCFCN2024-10-14
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14
10192253065480DoverCardinal Health 200, LLCFCN2024-09-03
10192253065497DoverCardinal Health 200, LLCFCN2024-09-03
10192253065619DoverCardinal Health 200, LLCFCN2024-09-03
10192253065626DoverCardinal Health 200, LLCFCN2024-09-03
50192253065488DoverCardinal Health 200, LLCFCN2024-09-03
50192253065495DoverCardinal Health 200, LLCFCN2024-09-03
50192253065617DoverCardinal Health 200, LLCFCN2024-09-03
50192253065624DoverCardinal Health 200, LLCFCN2024-09-03
10192253051612DoverCardinal Health 200, LLCFCN2024-08-08
50192253051610DoverCardinal Health 200, LLCFCN2024-08-08
10850053289085SURGYCOSurgyco LLCFCN2023-12-15
10850053289092SURGYCOSurgyco LLCFCN2023-12-15
10850053289108SURGYCOSurgyco LLCFCN2023-12-15