EcoSonic 43394-04

GUDID 00620974003496

EcoSonic Descaler, 4G

Southmedic Incorporated

Medical device cleaning agent

• Primary Device ID: 00620974003496
• NIH Device Record Key: a5fd5e1a-1a12-4dee-8951-8b8adb1d404c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoSonic
• Version Model Number: 43394-04
• Catalog Number: 43394-04
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• 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(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com

Device Dimensions

• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0
• Total Volume: 4 Gallon
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974003496 [Unit of Use]
GS1	10620974003493 [Primary]

FDA Product Code

• FLG: Cleaner, ultrasonic, medical instrument

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: 2022-09-07
• Device Publish Date: 2022-08-30

Devices Manufactured by Southmedic Incorporated

• 00620974003687 - Oxy2Mask O2/EtCO2: 2024-02-05 Oxy2Mask O2/EtCO2 Plus
• 00620974003090 - Oxy2Pro: 2023-12-11 Oxy2Pro Procedural Plus Mask with Female Luer
• 00620974003106 - Oxy2Pro: 2023-12-11 Oxy2Pro Procedural Plus Mask with Male Luer
• 00620974003120 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid
• 00620974003137 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid Mask with Microsteam connector
• 00620974003151 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003168 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003175 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult