FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
10841767106652
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
81432
Device description
CHG ADULT CL DRESS TRAY
Published
2023-04-05
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767106655PackageGS130In Commercial Distribution
10841767106652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767106655008417671066558417671066550841767106655
1084176710665210841767106652

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
154424043
Device count
1
DM exempt
true
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
10841767195717Trinity Sterile, Inc.500502026-08-25
10841767100537Trinity Sterile, Inc.5007M2026-10-06
10841767104696Trinity Sterile, Inc.826042023-07-28
10841767104795Trinity Sterile, Inc.812112023-06-07
10841767104818Trinity Sterile, Inc.812172023-06-07
10841767104825Trinity Sterile, Inc.812282023-06-07
10841767104849Trinity Sterile, Inc.81229A2023-06-07
10841767104962Trinity Sterile, Inc.812482023-06-05
10841767104979Trinity Sterile, Inc.812492023-06-05
10841767104986Trinity Sterile, Inc.812432023-06-07
10841767105143Trinity Sterile, Inc.816552023-04-04
10841767105181Trinity Sterile, Inc.81254B2023-06-05
10841767105211Trinity Sterile, Inc.816512023-03-29
10841767105327Trinity Sterile, Inc.816642023-06-02
10841767105334Trinity Sterile, Inc.813532023-06-05
10841767106614Trinity Sterile, Inc.813452023-06-05
10841767106621Trinity Sterile, Inc.813712023-06-02
10841767106645Trinity Sterile, Inc.814282023-06-02
10841767106720Trinity Sterile, Inc.816632023-04-04
10841767106737Trinity Sterile, Inc.816662023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395300MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395362MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395379MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395454MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395515MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395522MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395546MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395560MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395638MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14