FDA.report

ACS

Primary DI
00191072020802
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SJOH22E
Device description
OPEN HEART PACK
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LROGeneral surgery tray
OEZCardiovascular Procedure Kit

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072020802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072020802001910720208021910720208020191072020802

GMDN Terms

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
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

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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 DIBrandCompanyProduct codePublished
00191072241948ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
00191072241962ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
10884450111731Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450423629Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
20884450430815Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450430863Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
50198956219043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956220643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956300116CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956306866CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956311372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956327939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956328851CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956334760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956338218CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956345469CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956348736CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956359893CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956366365CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956379167CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956382150CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391329CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392616CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956394542CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956398427CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956399073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956406139CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24