ExSpiron Pediatric PadSets RMI-53040

GUDID 00851540007161

A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.

Senzime AB (Publ.)

Monitoring spirometer, electrical

• Primary Device ID: 00851540007161
• NIH Device Record Key: e4d64e42-c0d8-4e62-b964-5242de6c41be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExSpiron Pediatric PadSets
• Version Model Number: Pediatric
• Catalog Number: RMI-53040
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851540007161 [Primary]

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2024-02-02
• Device Publish Date: 2024-01-25

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: 2024-02-02A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
• 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: 2022-09-15 TetraGraph Xcom (Optional to use with TetraGraph)