BiTrac

GUDID 10841470108158

PULMODYNE INC

Ventilator breathing circuit, single-use
Primary Device ID10841470108158
NIH Device Record Keyb34729d6-d606-4d19-b193-c20d591f8681
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac
Version Model Number313-9074
Company DUNS030619483
Company NamePULMODYNE INC
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

Phone317-246-5505
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470108151 [Primary]
GS110841470108158 [Package]
Contains: 00841470108151
Package: [10 Units]
In Commercial Distribution

FDA Product Code

BZOSet, Tubing And Support, Ventilator (W Harness)

Sterilization

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

On-Brand Devices [BiTrac]

10841470108165313-9075
10841470108158313-9074
10841470108134313-9076
00841470108120313-9073
00841470108113313-9072
00841470108106313-9071
10841470108097313-9070

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