Triton System (Sponge)

GUDID 00859506006050

GAUSS SURGICAL, INC

Blood loss estimation application software

• Primary Device ID: 00859506006050
• NIH Device Record Key: 9fd5a683-d9c4-4f31-97ec-2db54e1dac44
• Commercial Distribution Discontinuation: 2018-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Triton System (Sponge)
• Version Model Number: GAUS-01
• Company DUNS: 968757448
• Company Name: GAUSS SURGICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859506006050 [Primary]

FDA Product Code

• PBZ: Image Processing Device For Estimation Of External Blood Loss

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-15
• Device Publish Date: 2016-10-05

Devices Manufactured by GAUSS SURGICAL, INC

• 00859506006258 - TRITON: 2023-03-27 TRITON 3L CANISTER INSERT KIT
• 00859506006005 - n/a: 2023-03-10 ACAIA PEARL SCALE 2.0
• 00859506006128 - Triton Canister System: 2018-07-26 MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025)
• 00859506006135 - Triton Canister System: 2018-07-26 MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)
• 00859506006067 - Triton Sponge System: 2018-07-06
• 00859506006081 - Triton Sponge System-Calibration Card: 2018-07-06
• 00859506006098 - Triton Sponge System- NUI Sensor Bracket: 2018-07-06 NUI Sensor Bracket for Tryten Cart
• 00859506006050 - Triton System (Sponge): 2018-05-15
• 00859506006050 - Triton System (Sponge): 2018-05-15