FDA.reportPublic FDA data

ACS

Primary DI
00191072199652
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ANSG81U
Device description
SWAN GANZ PACK - 205961
Published
2023-07-27
Public version status
New
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072199652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072199652001910721996521910721996520191072199652

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
00884450485163Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-23
B098AMS191180Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-07-22
00884450421581Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-21
10198956443013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956462717CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956469075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956488793CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956490192CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956493551CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956497207CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956499409CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956510715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956514966CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956518605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956520653CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956527355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528543CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528635CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528802CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528949CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956529731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956530829CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531185CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531758CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531895CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532687CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532823CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956533479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20