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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450486962Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
10809160523162HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523179HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523186HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523209HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523216HalyardAVID MEDICAL, INC.OEZ2026-06-09
10198956182264CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956394766CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956444454CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956473263CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956477643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956478824CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956483880CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956493520CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956494282CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956495166CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956495272CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496194CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496491CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496538CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496729CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496736CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496743CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496828CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497627CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497795CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08