FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
10841767106720
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
81663
Device description
CENTRAL LINE DRESSING KIT
Published
2023-04-04
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
00841767106723PackageGS130In Commercial Distribution
10841767106720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767106723008417671067238417671067230841767106723
1084176710672010841767106720

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
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
10841767106652Trinity Sterile, Inc.814322023-04-05
10841767106737Trinity Sterile, Inc.816662023-06-02
10841767106744Trinity Sterile, Inc.816672023-05-31
10841767106898Trinity Sterile, Inc.853872023-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956477278CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-08
10198956487765CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-05
10198956428942CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956476639CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956479852CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10653160393726MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10653160393733MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10193489111224MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-08-04
10193489190106MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190113MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190120MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190151MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
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10193489112184MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112191MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112207MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112214MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112221MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112238MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112115MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112122MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112139MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11