FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106496619
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN30AAP10
Catalog number
SAN30AAP10
Device description
ACC ANGIO
Published
2023-11-17
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
50197106496617PackageGS16In Commercial Distribution
10197106496619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710649661750197106496617
1019710649661910197106496619

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 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
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
10198956542402CARDINAL 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