FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956533387
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN43RAN21
Catalog number
SAN43RAN21
Device description
RADIAL ANGIOGRAPHY PACK
Published
2026-07-27
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
50198956533385PackageGS13In Commercial Distribution
10198956533387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653338550198956533385
1019895653338710198956533387

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 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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486191Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486207Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450487921Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-29
10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956352377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956353572CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956446816CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956474048CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956481350CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956489172CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956494527CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956505124CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956511309CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956512627CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517196CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517325CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956519213CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956521698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956523951CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528796CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528888CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529045CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529205CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530546CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531246CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531345CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956533486CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956534209CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27