FDA.reportPublic FDA data

ACS

Primary DI
00191072109002
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
HSCL01B
Device description
CENTRAL LINE TRAY
Published
2020-04-06
Public version status
Update
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
OFFCentral venous catheter tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072109002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072109002001910721090021910721090020191072109002

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile 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
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
10193489413670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-07-29
10193489212143Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489212655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489215205Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489376364Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489382747Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489409420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489411232Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489416534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489420210Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421569Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421675Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489422061Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489433135Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489456028Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489377194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489377354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489422689Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489423099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489423105Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489399912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
10193489399936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
10193489482164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-08-04
10193489442441Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-07-24