FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106317431
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE11AN104
Catalog number
SNE11AN104
Device description
NEURO EMBOLISM PACK
Published
2023-06-15
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106317431PackageGS13In Commercial Distribution
10197106317433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710631743150197106317431
1019710631743310197106317433

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system reference patchA component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450148228Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-19
10809160530795HalyardAVID MEDICAL, INC.OEZ2026-08-19
10198956502512CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956539082CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956548084CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956556881CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557789CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10809160530252HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530337HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530535HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530634HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530665HalyardAVID MEDICAL, INC.OEZ2026-08-18
10198956494800CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956500501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956522619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956535053CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956548770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956549418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550919CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956553293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
B098AMS196180Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-08-16