FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106587256
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21BPAPA
Catalog number
SBA21BPAPA
Device description
BREAST PACK
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106587254PackageGS12In Commercial Distribution
10197106587256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710658725450197106587254
1019710658725610197106587256

GMDN Terms#

Term, Definition table
TermDefinition
Pleurocentesis/paracentesis kitA collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
10809160523063HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523070HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523094HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523100HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523124HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523131HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523223HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523230HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523247HalyardAVID MEDICAL, INC.LRO2026-06-09
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956359024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956364783CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956443518CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956466012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956467484CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469204CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956473423CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477292CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477339CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483378CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483903CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956484368CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956487406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956492660CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956493667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08