FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106407255
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN31PBSG5
Catalog number
SAN31PBSG5
Device description
PICC LINE
Published
2023-08-11
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
PXBPercutaneous introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXBPercutaneous Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106407255PackageGS15In Commercial Distribution
10197106407257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710640725550197106407255
1019710640725710197106407257

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

Sterilization Methods#

Method table
Method

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
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
B090LRKIT0Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.PXB2024-04-24
10197106407257CARDINAL HEALTHCardinal Health 200, LLCPXB2023-08-11
10197106114018CARDINAL HEALTHCardinal Health 200, LLCPXB2023-02-07
50197106114016CARDINAL HEALTHCardinal Health 200, LLCPXB2023-02-07
00863092000101Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.PXB2022-12-15
50885403242333N/ACAREFUSION 2200, INCPXB2018-07-26