FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956536258
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANOCCPN66
Catalog number
SANOCCPN66
Device description
CATH PACK
Published
2026-08-17
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
50198956536256PackageGS12In Commercial Distribution
10198956536258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653625650198956536256
1019895653625810198956536258

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956513563CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956533707CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956554580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956555310CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
B098AMS14762A0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-16
00884450488843Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-15
B098AMS196570Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-14
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