FDA.reportPublic FDA data

ACS

Primary DI
00191072232373
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIUM73C
Device description
UMBILICAL LINE PACK
Published
2024-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00191072232373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072232373001910722323731910722323730191072232373

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
010334675
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191072241948ACSAMMV04AE2026-03-24
00191072241962ACSFDCR00AE2026-03-24
00191072241979ACSLKTK16AB2026-03-24
00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
00191072242020ACSFDSA15N2026-03-24
00191072242037ACSBPHA89E2026-03-24
00191072241757ACSSPSA58S2026-02-19
00191072241764ACSLLGT12F2026-02-19
00191072241801ACSCIEY01G2026-02-19
00191072241818ACSWEHF12B2026-02-19
00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
00191072241894ACSIHTR90N2026-02-19
00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19

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
10197106625798CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-06-18
50197106625796CARDINAL 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