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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884450837911Merit Medical®Merit Medical Systems, Inc.OEX2025-05-31
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
10884450565930Merit Medical®Merit Medical Systems, Inc.OEX2021-04-08
10884450432058Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
10884450534356Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
10884450537814Merit Medical®Merit Medical Systems, Inc.OEX2021-01-14
10884450530709Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
20884450527034Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
20884450532762Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
10884450532796Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
20884450524323Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
10884450505110Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
10884450505103Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
10884450485283Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-07-08
20884450474093Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-06-11
20884450480681Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-05-13
20884450409545Merit Medical®Merit Medical Systems, Inc.OEX2020-05-05
10884450482671Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-23
10884450482954Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-23
20884450482944Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-17
20884450475649Merit Medical®Merit Medical Systems, Inc.OEX2020-02-25
20884450476080Merit Medical®Merit Medical Systems, Inc.OEX2020-02-25
10884450476908Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-25
10884450476915Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-24
20884450474062Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
20884450474079Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
20884450474086Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
10884450465322Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-01-13