TetraGraph Xcom SEN 2010

GUDID 07350012440145

TetraGraph Xcom (Optional to use with TetraGraph)

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 07350012440145
• NIH Device Record Key: 1bd4a9ad-8017-4eca-b5ba-8fd465eb4db1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TetraGraph Xcom
• Version Model Number: SEN 2010 TetraGraph Xcom
• Catalog Number: SEN 2010
• Company DUNS: 559976316
• Company Name: Senzime AB (Publ.)
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350012440145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220530

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2022-09-15
• Device Publish Date: 2022-09-07

Devices Manufactured by Senzime AB (Publ.)

• 07350012440176 - TetraSens: 2024-05-06 TetraSens with EZconnect
• 07350012440190 - TetraSens Pediatric: 2024-05-06 TetraSens Pediatric EZConnect
• 07350012440251 - TetraSensitive: 2024-05-06 TetraSensitive with EZconnect
• 00851540007161 - ExSpiron Pediatric PadSets: 2024-02-02 A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor fo
• 07350012440206 - TetraSensitive: 2023-11-14 TetraSensitive
• 07350012440107 - TetraGraph Philips Interface: 2022-09-15 TetraGraph Philip Interface (Optional to use with TetraGraph)
• 07350012440114 - TetraSens Pediatric: 2022-09-15 TetraSens Pediatric electrode
• 07350012440145 - TetraGraph Xcom: 2022-09-15TetraGraph Xcom (Optional to use with TetraGraph)
• 07350012440145 - TetraGraph Xcom: 2022-09-15 TetraGraph Xcom (Optional to use with TetraGraph)