trophon3

GUDID 09350855000740

Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag

NANOSONICS LIMITED

Atomized-chemical device disinfector

• Primary Device ID: 09350855000740
• NIH Device Record Key: 2eddf829-3dc0-4cf0-a4bb-a425b7ffc65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: trophon3
• Version Model Number: N05035-US
• Company DUNS: 741021943
• Company Name: NANOSONICS LIMITED
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us
• Phone: 1-844-876-7466
• Email: customerservice@nanosonics.us

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F
• Special Storage Condition, Specify: Between 0 and 0 * -20 °C to +60 °C / -4 °F to +140 °F

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350855000740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250434

FDA Product Code

• OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-22
• Device Publish Date: 2025-08-14

Devices Manufactured by NANOSONICS LIMITED

• 09350855000740 - trophon3: 2025-08-22Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag
• 09350855000740 - trophon3: 2025-08-22 Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag
• 09350855000573 - trophon Wireless Ultrasound Probe Holder: 2024-11-04 Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Inst
• 09350855000207 - trophon AcuTrace Operator Card: 2024-06-05 RFID Operator card
• 09350855000214 - trophon AcuTrace Medical Instrument Tag: 2024-06-05 RFID Medical Instrument tag
• 09350855000566 - trophon Curved Probe Positioner: 2022-07-18 Curved Probe Positioner
• 09350855000542 - trophon Chemical Indicator: 2022-05-20 Chemical Indicator
• 09350855000047 - Trophon Chemical Indicator: 2021-02-19 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)
• 09350855000054 - Trophon Chemical Indicator: 2021-02-19 Chemical Indicator US SP-P18 (NNA VARIANT)