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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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