FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594456214
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23VCDUA
Catalog number
SAN23VCDUA
Device description
VESSEL CATHETER INSERTION TRAY
Published
2022-01-28
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
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594456212PackageGS110In Commercial Distribution
10195594456214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559445621250195594456212
1019559445621410195594456214

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
00849884007824VYGONVygon CorporationOKE2026-09-25
10198956578548CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-25
10198956539907CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956569287CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956572973CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956552678CARDINAL HEALTHCardinal Health 200, LLCOKE2026-08-26
00199972000528CuraplexBOUND TREE MEDICAL, LLCOKE2026-08-15
10198956519633CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
10198956530409CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
10198956524644CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-20
10198956504141CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956527980CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956468474CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-23
10198956421448CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-08
10198956464070CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956492936CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956320161CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
10198956381469CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
10194717120162Regard™ROI CPS, LLCOKE2024-10-08
10194717120094Regard™ROI CPS, LLCOKE2024-10-02
10194717119807Regard™ROI CPS, LLCOKE2024-06-26
10194717119234Regard™ROI CPS, LLCOKE2024-04-12
10194717118336Regard™ROI CPS, LLCOKE2024-01-26
10194717117551Regard™ROI CPS, LLCOKE2023-06-21
10194717116660Regard™ROI CPS, LLCOKE2023-01-13
10195594396510CARDINAL HEALTHCardinal Health 200, LLCOKE2022-04-29
10194717115717Regard™ROI CPS, LLCOKE2022-04-14
10195594443092CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-26
10195594385910CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594423025CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28