FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106756438
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
OTC
false
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

Sterilization Methods#

Method table
Method

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
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
10197106756430CARDINAL 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