TRITON FG-12022

GUDID 00859506006258

TRITON 3L CANISTER INSERT KIT

GAUSS SURGICAL, INC

Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label

• Primary Device ID: 00859506006258
• NIH Device Record Key: 88c566db-f201-4f8f-b323-fd240f48a326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRITON
• Version Model Number: FG-12022
• Catalog Number: FG-12022
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to ultraviolet light
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859506006258 [Primary]
GS1	10859506006255 [Package]; Package: pack [50 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2023-03-27
• Device Publish Date: 2022-12-22

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• 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