Clearflo PFT Filter in bag

GUDID 07540261014215

Clearflo PFT Filter. Used with tremoFlo Airwave Oscillometry System.

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult
Primary Device ID07540261014215
NIH Device Record Key2bdbf1f6-f364-4867-87a6-3e24b60b6fb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearflo PFT Filter in bag
Version Model Number101421
Company DUNS257777701
Company NameThorasys Thoracic Medical Systems Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5143848555
Emailtechsupport@thorasys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540261014215 [Primary]
GS107540261016356 [Package]
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNVImpedance Measuring Device Utilizing Oscillation Techniques

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-16

Devices Manufactured by Thorasys Thoracic Medical Systems Inc

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07540261020698 - tF Calibrated Reference Load 15cmH2O (2 Years Edition)2024-09-30 2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
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07540261021817 - tf C-100 Kit Vitalograph - Healthcare Edition (28500)2024-09-30 The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph'
07540261020797 - tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition2024-04-22 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/L2021-11-11 Reference load (15 cm cm H2O.s/L) to verify TremoFlo Oscillometry System calibration.
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07540261025853 - tremoflo C-100 Airwave Oscillometry System & Acces2018-08-20 Airwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power supply, ethernet cable, user ma

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