FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956491267
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN56IPI28
Catalog number
SAN56IPI28
Device description
IFCH PICC PACK
Published
2026-06-03
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
PXKVascular access port kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXKVascular Access Port KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956491265PackageGS13In Commercial Distribution
10198956491267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649126550198956491265
1019895649126710198956491267

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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 Temperature00

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956446113CARDINAL HEALTHCardinal Health 200, LLCPXK2026-06-03
10198956435469CARDINAL HEALTHCardinal Health 200, LLCPXK2026-06-01
10197106598474CARDINAL HEALTHCardinal Health 200, LLCPXK2024-04-17
10197106594995CARDINAL HEALTHCardinal Health 200, LLCPXK2024-04-09
10197106577905CARDINAL HEALTHCardinal Health 200, LLCPXK2024-03-21
10197106588680CARDINAL HEALTHCardinal Health 200, LLCPXK2024-03-05
10197106590508CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-29
10197106566695CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-28
10197106545041CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-21
10197106544686CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-19
10197106573617CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-13
10197106563229CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-12
10197106512999CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-09
10197106512937CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-08
10197106544242CARDINAL HEALTHCardinal Health 200, LLCPXK2024-02-07
10197106525890CARDINAL HEALTHCardinal Health 200, LLCPXK2024-01-23
10197106532577CARDINAL HEALTHCardinal Health 200, LLCPXK2024-01-23
10197106523933CARDINAL HEALTHCardinal Health 200, LLCPXK2024-01-16
10197106503034CARDINAL HEALTHCardinal Health 200, LLCPXK2024-01-10
10197106531488CARDINAL HEALTHCardinal Health 200, LLCPXK2024-01-09
10197106485958CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-29
10197106532706CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-29
10197106516737CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-28
10197106467565CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-19
10197106510872CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-19
10197106486160CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-14
10197106518762CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-13
10197106502624CARDINAL HEALTHCardinal Health 200, LLCPXK2023-12-08
10197106474525CARDINAL HEALTHCardinal Health 200, LLCPXK2023-11-29
10197106473542CARDINAL HEALTHCardinal Health 200, LLCPXK2023-11-17