Triton Canister System

Basic Information

• Brand Name: Triton Canister System
• Primary DI: 00859506006135
• Version / Model: PN 11035
• Company Name: GAUSS SURGICAL, INC
• Labeler DUNS: 968757448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-25
• Public Version: 1
• Public Version Date: 2018-07-26
• Public Version Status: New
• Public Device Record Key: 3507efcd-f8fa-4d86-848d-ab9745d589ac

Device Description

MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBZ	Image Processing Device For Estimation Of External Blood Loss	General Hospital	880.2750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61697	Blood loss estimation canister insert/label	A device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859506006135	GS1

Premarket Submissions

Submission Number	Supplement Number
K142801	000