FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956037272
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANCGCCC35
Catalog number
SANCGCCC35
Device description
CARDIAC CATH PACK CON
Published
2025-04-09
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
50198956037272PackageGS14In Commercial Distribution
10198956037274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895603727250198956037272
1019895603727410198956037274

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450220306Merit Medical®Merit Medical Systems, Inc.OEQ2026-06-03
00884450487006Merit Medical®Merit Medical Systems, Inc.OEQ2026-06-03
10198956334915CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956477018CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956489462CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956491656CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956493223CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956493445CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956428324CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956444355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956460973CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956469037CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956471696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956476240CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956477711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956487505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956488977CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489295CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489561CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490307CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490420CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956491342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492493CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492875CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956493544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956494190CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
00884450474570Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-29
00884450430057Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
00884450487549Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
10809160522035HALYARDAVID MEDICAL, INC.OEQ2026-05-27