Device
2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
Manufacturer
Thorasys Thoracic Medical Systems Inc
Thorasys Thoracic Medical Systems Inc
Model: 102280
DI: 07540261022807
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1d6b812a-8b7b-4ed3-bffd-d5e588a4deb5
Distribution Status:
In Commercial Distribution
DUNS Number:
257777701
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07540261022807
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35282
Name: Pulmonary function analysis system, adult
Definition:
A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].
FDA Product Codes
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
Premarket Submissions
Submission Number:
K170185
Supplement Number:
000