TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L

GUDID 07540261010590

Reference load (15 cm cm H2O.s/L) to verify TremoFlo Oscillometry System calibration.

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult
Primary Device ID07540261010590
NIH Device Record Key8fd50949-ba85-4814-8441-0829f7da0ead
Commercial Distribution StatusIn Commercial Distribution
Brand NameTremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L
Version Model Number101059
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com
Phone5143848555
Emailtechsupport@thorasys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540261010590 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-11
Device Publish Date2021-11-03

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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