FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380170805
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CA071187JS
Catalog number
CA071187JS
Device description
Custom Lock Box 10 Top Load - Jersey Shore Medical Center Only
Published
2020-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NNLCONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380170805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538017080510885380170805

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

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Primary DI, Brand, Company table
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10885380169618CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380169625CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380168833CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168840CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168871CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168888CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20