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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450846148Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-25
00884450428320Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-24
00884450470831Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-24
00884450484203Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-24
10809160527757HalyardAVID MEDICAL, INC.OEZ2026-07-23
00884450376546Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450488751Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450499276Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
10809160527719HalyardAVID MEDICAL, INC.OEZ2026-07-22
10809160527658HalyardAVID MEDICAL, INC.OEZ2026-07-21
10197106917619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956119505CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956173552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956326583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956343337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956346758CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956427723CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956439375CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956462045CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956487666CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956490031CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956492967CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956493742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496248CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956500259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956502673CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956504912CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956509665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956510463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20