FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956491922
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN45PCIMB
Catalog number
SAN45PCIMB
Device description
PACK SJD PACEMAKER PMRMI
Published
2026-07-06
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
50198956491920PackageGS12In Commercial Distribution
10198956491922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649192050198956491920
1019895649192210198956491922

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956488465CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956494794CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956496262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956497214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956502888CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956509443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956513891CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525016CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525207CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526815CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956527430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10809160526484HalyardAVID MEDICAL, INC.OEZ2026-07-06
10809160526514HalyardAVID MEDICAL, INC.OEZ2026-07-06
00884450423790Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-03
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450486962Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09