FDA.reportPublic FDA data

ACS

Primary DI
00191072064547
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
WPPI47H
Device description
CATHETER PORT INSERTION 152925
Published
2020-05-11
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072064547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072064547001910720645471910720645470191072064547

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
10198956478107CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956518131CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956526983CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956528208CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10809160526859HalyardAVID MEDICAL, INC.OES2026-07-08
10198956463400CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10198956525993CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10809160526361HalyardAVID MEDICAL, INC.OES2026-06-26
10809160526262HalyardAVID MEDICAL, INC.OES2026-06-25
10809160525937HalyardAVID MEDICAL, INC.OES2026-06-24
10809160525968HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526019HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526132HalyardAVID MEDICAL, INC.OES2026-06-24
10198956415553CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-23
10809160525869HalyardAVID MEDICAL, INC.OES2026-06-23
10809160525890HALYARDAVID MEDICAL, INC.OES2026-06-23
10809160525234HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525555HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525579HalyardAVID MEDICAL, INC.OES2026-06-22
10809160523148HalyardAVID MEDICAL, INC.OES2026-06-09
10809160523193HalyardAVID MEDICAL, INC.OES2026-06-09
10198956483590CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956490512CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956496224CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10198956506718CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
10809160522981HalyardAVID MEDICAL, INC.OES2026-06-08
10198956471757CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10198956495777CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10809160522639HalyardAVID MEDICAL, INC.OES2026-06-04
10198956459960CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-03