ActivaTek Ionto4 Butterfly 4511

GUDID 20768627016319

ActivaTek Ionto4 Butterfly (12)

NORTH COAST MEDICAL, INC.

Multi-modality electrotherapy system

• Primary Device ID: 20768627016319
• NIH Device Record Key: b895cd61-b3bb-457f-bd98-0bf3a1db2abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaTek Ionto4 Butterfly
• Version Model Number: NC89378
• Catalog Number: 4511
• Company DUNS: 060121928
• Company Name: NORTH COAST MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com
• Phone: 4087765000
• Email: custserv@ncmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10768627016312 [Primary]
GS1	20768627016319 [Package]; Contains: 10768627016312; Package: Master Carton [50 Units]; In Commercial Distribution

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

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: 2025-04-10
• Device Publish Date: 2025-04-02

Devices Manufactured by NORTH COAST MEDICAL, INC.

• 10768627016282 - ActivaTek Ionto4 Kit: 2025-04-10 ActivaTek Ionto4 Kit SM (12)
• 20768627016296 - ActivaTek Ionto4 Kit: 2025-04-10 ActivaTek Ionto4 Kit MD (12)
• 20768627016302 - ActivaTek Ionto4 Kit: 2025-04-10 ActivaTek Ionto4 Kit LG (12)
• 20768627016319 - ActivaTek Ionto4 Butterfly: 2025-04-10ActivaTek Ionto4 Butterfly (12)
• 20768627016319 - ActivaTek Ionto4 Butterfly: 2025-04-10 ActivaTek Ionto4 Butterfly (12)
• 00768627001632 - Norco: 2025-04-03 Norco Eco-Stim TENS + EMS
• 10768627160282 - Blue Diamond: 2023-09-11 Blue Diamond Dry Needle .16x13mm (qty. 100)
• 10768627160299 - Blue Diamond: 2023-09-11 Blue Diamond Dry Needle .18x13mm (100)
• 10768627160305 - Blue Diamond: 2023-09-11 Blue Diamond Dry Needle .20x13mm (100)