FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586055
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV57EVO10
Catalog number
SCV57EVO10
Device description
EVAR PACK
Published
2026-09-22
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956586053PackageGS12In Commercial Distribution
10198956586055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658605350198956586053
1019895658605510198956586055

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956339255CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956504271CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956577664CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582149CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582170CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582996CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956583238CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956583535CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956583566CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956584549CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956584679CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956585973CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956587045CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956587076CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956588776CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956588981CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956589223CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956589308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956589353CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956133648CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956395428CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956533691CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956551114CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956551213CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956575936CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21
10198956577442CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-21