Triton Sponge System- NUI Sensor Bracket

GUDID 00859506006098

NUI Sensor Bracket for Tryten Cart

GAUSS SURGICAL, INC

Blood loss estimation application software

• Primary Device ID: 00859506006098
• NIH Device Record Key: 6d336c36-b768-4b6c-9e69-9e6d18e3423e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triton Sponge System- NUI Sensor Bracket
• Version Model Number: PN 11028
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00859506006098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163507

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: 2018-07-06
• Device Publish Date: 2017-08-09

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: 2018-07-06NUI Sensor Bracket for Tryten Cart
• 00859506006098 - Triton Sponge System- NUI Sensor Bracket: 2018-07-06 NUI Sensor Bracket for Tryten Cart
• 00859506006050 - Triton System (Sponge): 2018-05-15