FDA.reportPublic FDA data

ACS

Primary DI
00191072107268
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIST11F
Device description
#1 SPECIMEN TUBE PK,STRL F/G (PS 907131)
Published
2020-04-06
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
OFZBlood specimen collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFZBlood Specimen Collection Kit (Excludes Hiv Testing)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072107268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072107268001910721072681910721072680191072107268

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
00810185250189TherapakTherapak LLCOFZ2025-08-11
00810185250196TherapakTherapak LLCOFZ2025-08-11
10198956098077CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
50198956098075CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
10198956070578CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
50198956070576CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
10809160416594Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
20809160416591Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
00810094575809CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
00810094575854CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
07312058462857TherapakTherapak LLCOFZ2022-12-21
00860193001730KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
00860193001747KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
10195594754068CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
50195594754066CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
10809160371947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
20809160371944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
10195594560362CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
50195594560360CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
10888439848830CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
50888439848838CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
00860193001709AlloSure Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001716Allomap Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001723HeartCare Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00812277035247CuraplexBOUND TREE MEDICAL, LLCOFZ2019-07-01
10809160240779Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
20809160240776Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
15060498451533Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
25060498451530Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
10809160149454Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2017-06-06