FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488862651
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PVDHOTNHC
Catalog number
PVDHOTNHC
Device description
KIT, DECLOT ACCESS
Published
2018-02-26
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
50887488862659PackageGS11In Commercial Distribution
10887488862651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748886265950887488862659
1088748886265110887488862651

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic implant introduction kitA collection of sterile devices intended to assist the surgical introduction of an implantable cardiothoracic device (e.g., implantable cardiac monitor) within a subcutaneous cavity in the thorax; it is not intended for implantation within an organ (i.e., heart, lungs or blood vessels). It includes an implant introducer and at least one additional invasive device (e.g., scalpel). 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
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