FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594227432
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANOCSPAMA
Catalog number
SANOCSPAMA
Device description
SENTINEL RADIAL SHEATH PACK
Published
2021-11-12
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
OEXCardiovascular catheter sheath introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEXCardiovascular Catheter Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594227430PackageGS115In Commercial Distribution
10195594227432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559422743050195594227430
1019559422743210195594227432

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 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450837917Merit Medical®Merit Medical Systems, Inc.OEX2025-05-31
20884450837911Merit Medical®Merit Medical Systems, Inc.OEX2025-05-31
00884450760901Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
00884450760918Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450760905Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450760912Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450525191COBRA-OSMerit Medical Systems, Inc.OEX2022-05-19
50195594227430CARDINAL HEALTHCardinal Health 200, LLCOEX2021-11-12
10884450565930Merit Medical®Merit Medical Systems, Inc.OEX2021-04-08
00884450432051Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
10884450432058Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
00884450534359Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
10884450534356Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
00884450537817Merit Medical®Merit Medical Systems, Inc.OEX2021-01-14
10884450537814Merit Medical®Merit Medical Systems, Inc.OEX2021-01-14
00884450530702Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
10884450530709Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
00884450527030Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
20884450527034Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
00884450532768Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
20884450532762Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
00884450532799Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
10884450532796Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
00884450524329Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
20884450524323Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
00884450505113Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
10884450505110Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
00884450505106Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
10884450505103Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
00884450485286Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-07-08