FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106756430
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA56DCSJA
Catalog number
SMA56DCSJA
Device description
D AND C PACK
Published
2024-10-10
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
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
50197106756438PackageGS12In Commercial Distribution
10197106756430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710675643850197106756438
1019710675643010197106756430

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106408506CARDINAL HEALTHCardinal Health 200, LLCPFK2023-08-15
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