FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439087079
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4FDPHP1
Catalog number
SAN4FDPHP1
Device description
DIGITAL PROCEDURE PACK
Published
2018-08-06
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
OFHDigital angiography tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFHDigital Angiography TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439087077PackageGS15In Commercial Distribution
10888439087079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843908707750888439087077
1088843908707910888439087079

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. 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 intended to be sterilized prior to use.

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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956575387CARDINAL HEALTHCardinal Health 200, LLCOFH2026-10-06
10198956363359CARDINAL HEALTHCardinal Health 200, LLCOFH2026-03-31
10197106807927CARDINAL HEALTHCardinal Health 200, LLCOFH2024-12-11
50197106807925CARDINAL HEALTHCardinal Health 200, LLCOFH2024-12-11
10197106636312CARDINAL HEALTHCardinal Health 200, LLCOFH2024-07-10
50197106636310CARDINAL HEALTHCardinal Health 200, LLCOFH2024-07-10
10197106220092CARDINAL HEALTHCardinal Health 200, LLCOFH2023-05-11
50197106220090CARDINAL HEALTHCardinal Health 200, LLCOFH2023-05-11
10195594385620CARDINAL HEALTHCardinal Health 200, LLCOFH2021-10-15
50195594385628CARDINAL HEALTHCardinal Health 200, LLCOFH2021-10-15
10887488344201CARDINAL HEALTHCardinal Health 200, LLCOFH2016-07-07