FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594700942
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV12OLROL
Catalog number
SCV12OLROL
Device description
OPEN HEART LEG PK SRMH 182423
Published
2022-06-10
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594700940PackageGS11In Commercial Distribution
10195594700942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559470094050195594700940
1019559470094210195594700942

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450450949Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-11
00884450108765Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-10
00884450487334Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-10
00884450486436Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
00884450488812Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
10198956119437CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956345942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956360358CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956365056CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956418424CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956421479CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956439870CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956462182CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956480834CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956483408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956485662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956488861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956490871CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956491502CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492332CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956496415CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956502420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503915CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504011CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504325CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956507104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956511057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956512603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09