FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956607590
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN3BCLKFN
Catalog number
SAN3BCLKFN
Device description
CATH LAB TRAY
Published
2026-10-26
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
50198956607598PackageGS12In Commercial Distribution
10198956607590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660759850198956607598
1019895660759010198956607590

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956590229CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956603837CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956606982CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608016CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608214CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956609068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956612730CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956614918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616738CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
B098AMS188920Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
B098AMS199310Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
00884450499214Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450501023Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450502082Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450431641Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-21
10809160541029Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-21
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