FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956516878
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA30SJPPA
Catalog number
SBA30SJPPA
Device description
SJ PEDIATRIC PACK
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956516876PackageGS13In Commercial Distribution
10198956516878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651687650198956516876
1019895651687810198956516878

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450498996Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-30
10809160528150HalyardAVID MEDICAL, INC.OEZ2026-07-30
10809160528167HalyardAVID MEDICAL, INC.OEZ2026-07-30
00884450431672Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-29
00884450144046Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-28
10809160528020HalyardAVID MEDICAL, INC.OEZ2026-07-28
10198956423527CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956442191CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956459830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956477131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956478893CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956482449CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956493605CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956494770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956496187CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956499379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956504684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505674CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956514188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956518742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956520684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521513CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524163CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27