FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488636450
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
14-0531A
Catalog number
14-0531A
Device description
STERILE SPECIMEN CUP KIT
Published
2016-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488636458PackageGS130In Commercial Distribution
10887488636450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748863645850887488636458
1088748863645010887488636450

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, sterileA sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
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10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
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14039943000221CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000238CRYO.SGreiner Bio - One GmbHKDT2022-12-06