PneumoTherm 5800-0-1

GUDID 00607411006906

PneumoTherm Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.

SALTER LABS

Respiratory apnoea monitoring system Respiratory apnoea monitoring system Respiratory apnoea monitoring system

• Primary Device ID: 00607411006906
• NIH Device Record Key: 1d0ec4ed-49ec-4b79-94a6-edcf2ebbcd94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PneumoTherm
• Version Model Number: 5800-0-1
• Catalog Number: 5800-0-1
• Company DUNS: 022721133
• Company Name: SALTER LABS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411006906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092685

FDA Product Code

• BZQ: Monitor, breathing frequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-17
• Device Publish Date: 2016-12-16

On-Brand Devices [PneumoTherm]

• 00607411889745: PneumoTherm™ Adaptor Cable "REUSABLE" 6" Wire for use with the PneumoTherm™ Thermocouple.
• 00607411006906: PneumoTherm Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Na
• 00607411006890: PneumoTherm™ Adaptor Cable (5810). The 5810 PneumoTherm™ Adaptor Cable is used as an interfa
• 10607411006873: PneumoTherm (Adult) Oral/Nasal Thermal Air Flow Sensor