BiTrac SE MaxShield

GUDID 10841470106994

PULMODYNE INC

CPAP/BPAP face mask, single-use
Primary Device ID10841470106994
NIH Device Record Keye13b91ef-7d4e-4046-9466-2a0cfcdf516d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac SE MaxShield
Version Model Number313-9056W
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
GS100841470106997 [Primary]
GS110841470106994 [Package]
Contains: 00841470106997
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 Date2016-10-14

On-Brand Devices [BiTrac SE MaxShield]

10841470106994313-9056W
10841470106635313-9055W
10841470106604313-9053W

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