FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439835036
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN43CCTS3
Catalog number
SAN43CCTS3
Device description
CARDIAC CATH
Published
2020-05-29
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439835036PackageGS13In Commercial Distribution
10888439835038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843983503650888439835036
1088843983503810888439835038

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
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
10809160539545HalyardAVID MEDICAL, INC.OES2026-10-01
10198956488847CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956516946CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956592308CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956593459CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956596641CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10809160539477HalyardAVID MEDICAL, INC.OES2026-09-30
10198956461963CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-29
10809160539262HalyardAVID MEDICAL, INC.OES2026-09-29
B098AMS194460Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-28
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459761850MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459766336MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459771224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459774126MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775437MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775666MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775673MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775680MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459778827MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459779985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459784996MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459786808MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25