FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488198484
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
SAN11EMNYS
Catalog number
SAN11EMNYS
Device description
STERILE EMBOLISM PACK
Published
2016-08-04
Public version status
Update
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488198482PackageGS13In Commercial Distribution
10887488198484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748819848250887488198482
1088748819848410887488198484

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular embolization implantation kitA collection of dedicated instruments intended to be used for the implantation of an embolization implant (implant not included). It typically includes devices for arterial access (e.g., needle, introducer, guidewires) and devices to assist introduction and positioning of the implant (e.g., catheter). 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
112164780
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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450431597Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450432105Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
B098AMS195240Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-26
10197106992753CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956169357CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956444263CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956466159CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956494923CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956529540CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956541566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956547506CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956553835CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562820CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570689CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956577640CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956578388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956580145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956582439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583283CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583412CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584839CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956585201CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25