FDA.reportPublic FDA data

ACS

Primary DI
00191072142467
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
IHOH21BF
Device description
OPEN HEART PACK
Published
2021-08-04
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072142467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072142467001910721424671910721424670191072142467

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
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
10809160527757HalyardAVID MEDICAL, INC.OEZ2026-07-23
00884450376546Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450488751Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450499276Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
10809160527719HalyardAVID MEDICAL, INC.OEZ2026-07-22
10809160527658HalyardAVID MEDICAL, INC.OEZ2026-07-21
10197106917619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956119505CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956173552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956326583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956343337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956346758CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956427723CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956439375CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956462045CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956487666CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956490031CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956492967CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956493742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496248CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956500259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956502673CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956504912CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956509665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956510463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956512894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956514942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956515369CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956516359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20