FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106625796
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
40-7483D
Catalog number
40-7483D
Device description
UMBILICAL CATH TRAY
Published
2024-06-18
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
PXJUmbilical catheter insertion tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXJUmbilical Catheter Insertion TrayGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106625796PackageGS112In Commercial Distribution
10197106625798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662579650197106625796
1019710662579810197106625798

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
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
10198956331631CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-03-23
50198956331639CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-03-23
10198956218871CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-02-09
50198956218879CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-02-09
10198956309777CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-22
50198956309775CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-22
10198956303478CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-07
50198956303476CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-07
10198956289567CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-17
50198956289565CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-17
10198956289826CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-11
50198956289824CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-11
10198956259607CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-28
50198956259605CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-28
10198956237346CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-10
10198956127500CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-06-25
50198956127508CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-06-25
10197106911426CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-04-01
50197106911424CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-04-01
10197106855423CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-13
50197106855421CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-13
10197106862438CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-02
50197106862436CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-02
10197106863985CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-12-11
50197106863983CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-12-11
00191072232373ACSAMERICAN CONTRACT SYSTEMS, INC.PXJ2024-11-24
10197106625798CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-06-18
10197106523568CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-01-24
50197106523566CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-01-24
10197106481103CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-12-01