BiTrac Vented

GUDID 10841470109353

PULMODYNE INC

CPAP/BPAP nasal mask, single-use
Primary Device ID10841470109353
NIH Device Record Key346f28ab-fb84-4f6e-8fe0-dd99efc49e13
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac Vented
Version Model Number313-9157
Company DUNS030619483
Company NamePULMODYNE 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

Phone317-246-5505
Emailinfo@pulmodyne.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109356 [Primary]
GS110841470109353 [Package]
Contains: 00841470109356
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-30
Device Publish Date2017-06-30

On-Brand Devices [BiTrac Vented]

10841470109353313-9157
10841470107106313-9156
10841470107090313-9155
10841470107083313-9154
10841470107076313-9153
10841470107069313-9152
10841470107052313-9151
10841470107045313-9150

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