FDA.reportPublic FDA data

ACS

Primary DI
00191072121851
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LLAK01A
Device description
PATIENT ADMIN KIT - NONSTERILE
Published
2021-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PWMAdmission kit (patient utensil)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWMAdmission Kit (Patient Utensil)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072121851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072121851001910721218511910721218510191072121851

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010334675
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
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
10198956407275CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-20
50198956407273CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-20
10198956392267CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-12
10198956371972CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-30
50198956371970CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-30
10198956344273CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-15
50198956344271CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-15
10198956331044CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
10198956333116CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
50198956331042CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
50198956333114CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
10198956247574CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
10198956289673CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
50198956247572CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
50198956289671CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
10198956286900CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-24
50198956286908CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-24
10198956119680CARDINAL HEALTHCardinal Health 200, LLCPWM2025-06-13
50198956119688CARDINAL HEALTHCardinal Health 200, LLCPWM2025-06-13
10198956106192CARDINAL HEALTHCardinal Health 200, LLCPWM2025-05-29
50198956106190CARDINAL HEALTHCardinal Health 200, LLCPWM2025-05-29
10198956063884CARDINAL HEALTHCardinal Health 200, LLCPWM2025-04-22
50198956063882CARDINAL HEALTHCardinal Health 200, LLCPWM2025-04-22
10197106822616CARDINAL HEALTHCardinal Health 200, LLCPWM2024-10-28
50197106822614CARDINAL HEALTHCardinal Health 200, LLCPWM2024-10-28
10197106700969CARDINAL HEALTHCardinal Health 200, LLCPWM2024-08-01
50197106700967CARDINAL HEALTHCardinal Health 200, LLCPWM2024-08-01
10197106630044CARDINAL HEALTHCardinal Health 200, LLCPWM2024-07-08
50197106630042CARDINAL HEALTHCardinal Health 200, LLCPWM2024-07-08
10195594729608CARDINAL HEALTHCardinal Health 200, LLCPWM2022-06-16