FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594231538
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
20-0032A
Catalog number
20-0032A
Device description
PORT ACCESS KIT WITHOUT NEEDLE
Published
2021-10-06
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
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
50195594231536PackageGS172In Commercial Distribution
10195594231538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559423153650195594231536
1019559423153810195594231538

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 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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106600191CARDINAL HEALTHCardinal Health 200, LLCPXK2024-03-21
10197106605745CARDINAL HEALTHCardinal Health 200, LLCPXK2024-03-18
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