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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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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