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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

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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