FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956245877
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANCGASMN8
Catalog number
SANCGASMN8
Device description
ANGIO SPLASH BWL, XXL, DRSG PK
Published
2025-11-19
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956245875PackageGS13In Commercial Distribution
10198956245877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895624587550198956245875
1019895624587710198956245877

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
00884450485163Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-23
B098AMS191180Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-07-22
00884450421581Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-21
10198956443013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956462717CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956469075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956488793CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956490192CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956493551CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956497207CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956499409CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956510715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956514966CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956518605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956520653CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956527355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528543CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528635CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528802CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528949CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956529731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956530829CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531185CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531758CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531895CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532687CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532823CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956533479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20