FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594227430
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
OTC
false
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

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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
10195594227432CARDINAL 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