PneumoTherm 5800T-0-10

GUDID 10607411006873

PneumoTherm (Adult) Oral/Nasal Thermal Air Flow Sensor

SALTER LABS

Respiratory apnoea monitoring system

• Primary Device ID: 10607411006873
• NIH Device Record Key: b8583717-080d-4768-b4dd-1a76bf6a61ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PneumoTherm
• Version Model Number: 5800T-0-10
• Catalog Number: 5800T-0-10
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411006876 [Primary]
GS1	10607411006873 [Package]; Contains: 00607411006876; Package: [10 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• 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