FDA.reportPublic FDA data

OEM CUSTOMER SPECIFIC

Primary DI
50192253050910
Brand
OEM CUSTOMER SPECIFIC
Company
Cardinal Health 200, LLC
Model
1270102159
Catalog number
1270102159
Device description
Pediatric Insert Cups, 13 mm, Beckman Coulter, Inc. Part Number 81916
Published
2025-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
50192253050910PrimaryGS10
10192253050912Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305091050192253050910
1019225305091210192253050912

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of 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 laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height13Millimeter

Regulatory Flags#

DUNS number
961027315
Device count
10000
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
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
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400310Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400334Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400358Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400075Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400105Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400129Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19