STS STS-AS-1000

GUDID 07290019579007

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viral-bacterial filter protecting the patient from the internal components of the device. The device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician’s computer via the STS software/App.

TECHNOPULM LTD

Diagnostic spirometer, professional

• Primary Device ID: 07290019579007
• NIH Device Record Key: 039d0297-82e6-411b-ab1e-005f9ec8753e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STS
• Version Model Number: 001
• Catalog Number: STS-AS-1000
• Company DUNS: 531899726
• Company Name: TECHNOPULM LTD
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 850 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019579007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240293

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2025-07-30
• Device Publish Date: 2025-07-22