Primary Device ID | 07540261013454 |
NIH Device Record Key | 351dc98a-85ae-44db-8498-dd579913827d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | tremoFlo US Software |
Version Model Number | 101345 |
Company DUNS | 257777701 |
Company Name | Thorasys Thoracic Medical Systems Inc |
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 | false |
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 |
Phone | 5143848555 |
techsupport@thorasys.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540261013454 [Primary] |
PNV | Impedance Measuring Device Utilizing Oscillation Techniques |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2018-01-16 |
07540261020797 - tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition | 2024-04-22 The tremoflo C-100 Airwave Oscillometry System and Accessories - Ganshorn SpiroDef Mouthpiece Variant Kit is compatible with the |
07540261010590 - TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L | 2021-11-11 Reference load (15 cm cm H2O.s/L) to verify TremoFlo Oscillometry System calibration. |
07540261019234 - tremoflo C-100 Airwave Oscillometry - Support Arm | 2021-11-11 Optional support arm accessory for the tremoflo C-100 system |
07540261025853 - tremoflo C-100 Airwave Oscillometry System & Acces | 2018-08-20 Airwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power supply, ethernet cable, user ma |
07540261009860 - TremoFlo C-100 Calibrated Reference Load 2 cm H2O. | 2018-07-06 Reference load to verify TremoFlo Oscillometry System calibration. |
07540261013362 - tF C-100 Unit-ClearFlo PFT filter compatible | 2018-07-06 Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compa |
07540261013454 - tremoFlo US Software | 2018-07-06tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the Forced Oscillation Tec |
07540261013454 - tremoFlo US Software | 2018-07-06 tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the |
07540261014215 - Clearflo PFT Filter in bag | 2018-07-06 Clearflo PFT Filter. Used with tremoFlo Airwave Oscillometry System. |