FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106954355
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANHDLHS18
Catalog number
SANHDLHS18
Device description
LEFT HEART CATH PK SH 36634
Published
2025-02-21
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106954353PackageGS14In Commercial Distribution
10197106954355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710695435350197106954353
1019710695435510197106954355

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
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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956478107CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956518131CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956526983CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956528208CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10809160526859HalyardAVID MEDICAL, INC.OES2026-07-08
10198956463400CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10198956525993CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10809160526361HalyardAVID MEDICAL, INC.OES2026-06-26
10809160526262HalyardAVID MEDICAL, INC.OES2026-06-25
10809160525937HalyardAVID MEDICAL, INC.OES2026-06-24
10809160525968HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526019HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526132HalyardAVID MEDICAL, INC.OES2026-06-24
10198956415553CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-23
10809160525869HalyardAVID MEDICAL, INC.OES2026-06-23
10809160525890HALYARDAVID MEDICAL, INC.OES2026-06-23
10809160525234HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525555HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525579HalyardAVID MEDICAL, INC.OES2026-06-22
10809160523148HalyardAVID MEDICAL, INC.OES2026-06-09
10809160523193HalyardAVID MEDICAL, INC.OES2026-06-09
10198956483590CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956490512CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956496224CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956506718CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10809160522981HalyardAVID MEDICAL, INC.OES2026-06-08
10198956471757CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10198956495777CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10809160522639HalyardAVID MEDICAL, INC.OES2026-06-04
10198956459960CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-03