FDA.reportPublic FDA data

ACS

Primary DI
00191072134196
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
YOCL56D
Device description
PICC CENTRAL LINE PACK
Published
2021-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072134196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072134196001910721341961910721341960191072134196

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
Ethylene Oxide

Regulatory Flags#

DUNS number
010334675
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
50198956293159CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956420708CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956424478CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956412321CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-19
50198956328134CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-10
50198956322194CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956339741CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956363531CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956401011CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956375688CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956377095CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956398625CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956336023CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359060CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359770CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956380446CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956323030CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956333992CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956344530CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956338096CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-17
50198956323115CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-13
50198956322682CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956333626CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956335200CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956356243CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956341591CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-30
50198956306118CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-23
50198956258585CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-22
00191072241610ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14
00191072241634ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14