Triton Sponge System- NUI Sensor Bracket

Basic Information

• Brand Name: Triton Sponge System- NUI Sensor Bracket
• Primary DI: 00859506006098
• Version / Model: PN 11028
• Company Name: GAUSS SURGICAL, INC
• Labeler DUNS: 968757448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6d336c36-b768-4b6c-9e69-9e6d18e3423e

Device Description

NUI Sensor Bracket for Tryten Cart

Device Characteristics

• Single Use: No
• 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: No
• 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
61696	Blood loss estimation application software	An application software program intended to be used for estimation of the quantity of external blood loss during a surgical procedure by analysis of images of blood-laden absorptive devices (e.g., swabs) and suction canisters. It is intended to run on an off-the-shelf or dedicated portable computerized device (e.g., smartphone, tablet, laptop) which may require an Internet connection. It does not store any patient demographic or clinical data. It typically includes upgrades to the software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859506006098	GS1

Premarket Submissions

Submission Number	Supplement Number
K163507	000