FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106584514
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN12CIWC6
Catalog number
SAN12CIWC6
Device description
CATH INSERTION PACK
Published
2024-02-26
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
OFECentral venous blood pressure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFECentral Venous Blood Pressure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106584512PackageGS14In Commercial Distribution
10197106584514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710658451250197106584512
1019710658451410197106584514

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
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
10198956418905CARDINAL HEALTHCardinal Health 200, LLCOFE2026-03-16
50198956418903CARDINAL HEALTHCardinal Health 200, LLCOFE2026-03-16
10198956270497CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956271142CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956272651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956133433CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
10198956133716CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133431CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133714CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
10198956114296CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-24
10198956070653CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
50198956070651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
10198956074347CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
50198956074345CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
10198956019737CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
50198956019735CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
10198956002685CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
50198956002683CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
10197106714690CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
50197106714698CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
10197106651339CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
50197106651337CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
10197106596593CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08
50197106596591CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08
50197106584512CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-26
10197106566534CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-08
50197106566532CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-08
10197106547397CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-29
50197106547395CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-29
10197106535172CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-16