FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956542402
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN43RAN22
Catalog number
SAN43RAN22
Device description
RADIAL ANGIOGRAPHY PACK
Published
2026-07-31
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
50198956542400PackageGS13In Commercial Distribution
10198956542402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654240050198956542400
1019895654240210198956542402

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. 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 intended to be sterilized prior to use.

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS10132C0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-03
00884450421994Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
00884450500927Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
10198956433182CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956456891CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956458840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956485266CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956534698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956537033CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538405CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538566CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538658CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538689CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956540897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956541375CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486191Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486207Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450487921Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-29
10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956352377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956353572CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956446816CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956474048CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956481350CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956489172CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956494527CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956505124CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956511309CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956512627CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27