FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106186983
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN13CLAJC
Catalog number
SAN13CLAJC
Device description
CATH LAB PACK
Published
2023-11-20
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106186983PackageGS12In Commercial Distribution
10197106186985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710618698350197106186983
1019710618698510197106186985

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system reference patchA component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
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
10198956394261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956406605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956428300CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956452589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956466395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956469099CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956481947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956483095CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956487284CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956494718CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956495586CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496118CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496231CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496521CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496637CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496811CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956498716CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956499362CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956499386CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956503526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956504257CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956505223CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956409859CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956453708CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956460256CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956467262CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956488021CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956492868CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956493131CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05