FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380163531
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C8552-12D
Catalog number
C8552-12D
Device description
Collection and Transport Swab Microorganism Collection and Transport System
Published
2018-12-18
Public version status
Update
Distribution status
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
LIODevice, specimen collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380163538PackageGS150In Commercial Distribution
50885380163539PackageGS110In Commercial Distribution
10885380163531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538016353820885380163538
5088538016353950885380163539
1088538016353110885380163531

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30609576901943Puritan® UniTranz-RT®Puritan Medical ProductsLIO2026-07-31
00609576901515Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00609576901713Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00609576901775Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00884999051690simpli-COLLECTABBOTT MOLECULAR INC.LIO2026-04-13
38053326011826BD FCTCOPAN ITALIA SPALIO2026-01-26
05060441760036binx ioBINX HEALTH LIMITEDLIO2025-09-03
05060441760043binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760033binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760040binx ioBINX HEALTH LIMITEDLIO2025-09-03
00848838066665Amies Clear Gel,Single Swab PK/500REMEL, INC.LIO2025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500REMEL, INC.LIO2025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50REMEL, INC.LIO2025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100REMEL, INC.LIO2025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50REMEL, INC.LIO2025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
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38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011710UriSponge™COPAN ITALIA SPALIO2025-03-12
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