FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106186985
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
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

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956594395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956607712CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956608641CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956611320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613294CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956614789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956615540CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
00884450037911Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-17
10198956571495CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956599406CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956606869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956607446CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
00884450501832Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-14
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12