EcoSonic 43394-04

GUDID 00620974003496

EcoSonic Descaler, 4G

Southmedic Incorporated

Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent 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