FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956590946
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN35BXB30
Catalog number
SAN35BXB30
Device description
HEART BIOPSY CARDIAC CATH PK
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
OFGCT biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956590944PackageGS17In Commercial Distribution
10198956590946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659094450198956590944
1019895659094610198956590946

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

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
10198956585874CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-22
10198956517097CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-21
10198956573079CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-04
10198956508293CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-27
10198956494589CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-06
10198956514713CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-23
10198956459946CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-01
10193489376449Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489417500Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489429336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489434958Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489442328Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489449211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489452143Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327028084Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327054588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327092696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489444995Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-04-30
10195327222550Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327214180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-04
10195327208165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327208554Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327213336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327195847Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327202934Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327204921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327197773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11
10195327199975Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11