FDA.report

Trinity Sterile, Inc.

Primary DI
00841767107331
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
81429
Device description
CENTRAL LINE TRAY
Published
2023-06-02
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

Related Records

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841767107331PackageGS120In Commercial Distribution
10841767107338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767107331008417671073318417671073310841767107331
1084176710733810841767107338

GMDN Terms

TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). 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, 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
Ethylene Oxide

Regulatory Flags

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
false
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 DIBrandModelCatalogPublished
50649111345775Trinity Sterile, Inc.94-19242024-12-16
50649111492691Trinity Sterile, Inc.96-3566A2024-12-16
50649111449701Trinity Sterile, Inc.96-36152024-12-16
10841767198275Trinity Sterile, Inc.T97-7052025-01-06
10841767101084Trinity Sterile, Inc.T97-7482024-10-30
10841767101091Trinity Sterile, Inc.T97-7512024-10-30
10841767198282Trinity Sterile, Inc.T97-7102024-10-30
10841767198312Trinity Sterile, Inc.T97-7422024-10-30
10841767198374Trinity Sterile, Inc.T97-7712024-10-30
10841767198381Trinity Sterile, Inc.T97-7722024-10-30
10841767198398Trinity Sterile, Inc.T97-7752024-10-30
10841767198404Trinity Sterile, Inc.T97-7762024-10-30
10841767198411Trinity Sterile, Inc.T97-7772024-10-30
10841767198428Trinity Sterile, Inc.T97-7782024-10-30
10841767101237Trinity Sterile, Inc.T98-8012024-10-28
10841767101114Trinity Sterile, Inc.T97-7932024-10-25
10841767198442Trinity Sterile, Inc.T97-7912024-10-25
10841767198466Trinity Sterile, Inc.T97-8102024-10-25
10841767198473Trinity Sterile, Inc.T97-8322024-10-25
10841767198497Trinity Sterile, Inc.T97-8472024-10-25

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