FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425686346
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN57AIOHF
Catalog number
SAN57AIOHF
Device description
ANGIO INSTRUMENT TRAY
Published
2016-07-14
Public version status
Update
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
OFACardiovascular surgical instruments tray (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425686344PackageGS120In Commercial Distribution
10885425686346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542568634450885425686344
1088542568634610885425686346

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106720967CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
50197106720965CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
10197106636435CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
10197106457368CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
10809160413616Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
10197106458495CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
50197106458493CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
00851788001174On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001730On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001747On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001006On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-08
10197106140499CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
10195594468828CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
10809160360156Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
00749756714402DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
10195594135928CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
10809160284223Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
00811870033568CUSTOM HEALTHCARE SYSTEMS, INC.Manus Medical, LLCOFA2019-07-29
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
00811870032264Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870032677Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24