Triton Canister System

GUDID 00859506006135

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

GAUSS SURGICAL, INC

Blood loss estimation canister insert/label
Primary Device ID00859506006135
NIH Device Record Key3507efcd-f8fa-4d86-848d-ab9745d589ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriton Canister System
Version Model NumberPN 11035
Company DUNS968757448
Company NameGAUSS SURGICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859506006135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBZImage Processing Device For Estimation Of External Blood Loss

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-26
Device Publish Date2018-06-25

On-Brand Devices [Triton Canister System]

00859506006135MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)
00859506006128MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025)
00859506006104Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)
00859506006043MediVac CRD 2L Scanning label and Insert (PN 11000 and PN 11025)
00859506006036MediVac CRD 3L Scanning label and Insert (PN 11000 and PN 11012)
00859506006029GAUS-02
00859506006012PN 11004

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