FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106408506
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCDCLD3
Catalog number
SMAOCDCLD3
Device description
D AND C PACK
Published
2023-08-15
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
PFKQuality control for molecular immunohematology tests

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFKQuality Control For Molecular Immunohematology TestsHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106408504PackageGS13In Commercial Distribution
10197106408506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710640850450197106408504
1019710640850610197106408506

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
10197106756430CARDINAL HEALTHCardinal Health 200, LLCPFK2024-10-10
50197106756438CARDINAL HEALTHCardinal Health 200, LLCPFK2024-10-10
10197106478349CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-16
50197106478347CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-16
10197106531235CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-09
50197106408504CARDINAL HEALTHCardinal Health 200, LLCPFK2023-08-15
10195594046347CARDINAL HEALTHCardinal Health 200, LLCPFK2021-04-23
50195594046345CARDINAL HEALTHCardinal Health 200, LLCPFK2021-04-23
08437013457040ID CORE CONTROLPROGENIKA BIOPHARMA, SAPFK2018-12-02
10888234102298BeadCheck HEA Ref-pA, Bulk and FillBIOARRAY SOLUTIONS LTDPFK2014-09-24
10888234102328BeadCheck HEA Ref-pB, Bulk and FillBIOARRAY SOLUTIONS LTDPFK2014-09-24
10888234102632Precise TypeTM HEA BeadCheck KitBIOARRAY SOLUTIONS LTDPFK2014-09-24