FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956590625
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11ANH12
Catalog number
SAN11ANH12
Device description
IR NEURO PACK
Published
2026-09-29
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
50198956590623PackageGS12In Commercial Distribution
10198956590625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659062350198956590623
1019895659062510198956590625

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596597CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956598188CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
00884450436004Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-29
10198956540491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956542136CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580770CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580978CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956589988CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590953CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
B098AMS194890Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-09-29
10809160539132HALYARDAVID MEDICAL, INC.OEQ2026-09-28
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956583931CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25