FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594966713
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PGCGOTN22
Catalog number
PGCGOTN22
Device description
KIT, IR PICC
Published
2021-03-23
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
50195594966711PackageGS13In Commercial Distribution
10195594966713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559496671150195594966711
1019559496671310195594966713

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956446113CARDINAL HEALTHCardinal Health 200, LLCPXK2026-06-03
10198956491267CARDINAL 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