FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106521779
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4JATCBA
Catalog number
SAN4JATCBA
Device description
PK ARTERIOGRAM CB
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OAAAid, visual, for nausea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAAAid, Visual, For NauseaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106521777PackageGS12In Commercial Distribution
10197106521779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710652177750197106521777
1019710652177910197106521779

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
10198956101845CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956102095CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956110205CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956101843CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956102093CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956110203CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956101296CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10198956101418CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101294CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101416CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10197106908792CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
50197106908790CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
10197106824443CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106835340CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106824441CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106835348CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106876275CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-20
10197106866498CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
50197106866496CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
10197106825150CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
50197106825158CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
10197106852248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106859025CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106852246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106859023CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106810248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
50197106810246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
10197106721049CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
50197106721047CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
10197106796108CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13