FDA.reportPublic FDA data

ACS

Primary DI
00191072197900
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BPHA89C
Device description
HYBRID ARTERIOGRAM PACK BHS
Published
2023-06-30
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072197900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072197900001910721979001910721979000191072197900

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
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
00191072242037ACSAMERICAN CONTRACT SYSTEMS, INC.OIP2026-03-24
50198956418415CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-24
50198956141207CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956338461CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956415209CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956329537CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956341997CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956381238CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956425802CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956318166CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956388183CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956395341CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956408430CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-06
50198956351392CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-03
50198956331431CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956372601CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956373868CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956377279CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956383973CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956386691CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956335613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956368710CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956297843CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-20
50198956322613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956330847CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956167566CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956324075CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956325935CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956345001CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956334920CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-29