FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956454545
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4JARH14
Catalog number
SAN4JARH14
Device description
HP ARTERIOGRAM DRAPE PACK
Published
2026-04-15
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
OERAngioscopic valvulotome kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OERAngioscopic Valvulotome KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956454543PackageGS12In Commercial Distribution
10198956454545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895645454350198956454543
1019895645454510198956454545

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
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
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956527669CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-16
10198956492035CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956494565CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956398689CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-06
10198956514102CARDINAL HEALTHCardinal Health 200, LLCOER2026-06-23
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
10198956454514CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-27
10198956448421CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-14
10198956422339CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
10198956387522CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-24
10198956385184CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
10198956341951CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
10198956339583CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
10198956268524CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
10198956266599CARDINAL HEALTHCardinal Health 200, LLCOER2025-11-21
10198956248502CARDINAL HEALTHCardinal Health 200, LLCOER2025-10-27
10198956169111CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
10198956160194CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
10198956144958CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
50198956144956CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
10198956136656CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
50198956136654CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
10198956110335CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-07