GUDID 00841470108144


Ventilator breathing circuit, single-use
Primary Device ID00841470108144
NIH Device Record Key5dcd622a-67a0-4a90-a25c-38ffb37563b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameValueTrac
Version Model Number313-9078
Company DUNS030619483
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470108144 [Primary]
GS110841470108141 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

BZOSet, Tubing And Support, Ventilator (W Harness)


Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2017-03-03

Devices Manufactured by PULMODYNE INC

10841470108165 - BiTrac2019-11-27
10841470108158 - BiTrac2019-11-27
00841470108144 - ValueTrac2019-11-27
00841470108144 - ValueTrac2019-11-27
10841470108134 - BiTrac2019-11-27
00841470108120 - BiTrac2019-11-27
00841470108113 - BiTrac2019-11-27
00841470108106 - BiTrac2019-11-27
10841470108097 - BiTrac2019-11-27

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