BiTrac MaxShield

GUDID 10841470106598

PULMODYNE INC

CPAP/BPAP face mask, single-use
Primary Device ID10841470106598
NIH Device Record Key92336f57-4dde-433f-b1f7-814d53accbec
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac MaxShield
Version Model Number313-9052W
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
GS100841470106591 [Primary]
GS110841470106598 [Package]
Contains: 00841470106591
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 Number3
Public Version Date2018-07-06
Device Publish Date2016-10-21

On-Brand Devices [BiTrac MaxShield]

10841470106642313-9057W
10841470106611313-9054W
10841470106598313-9052W

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.