BiTrac HC

GUDID 10841470107458

PULMODYNE INC

CPAP/BPAP face mask, single-use
Primary Device ID10841470107458
NIH Device Record Key61b67ad8-ecb6-42bd-b263-1961614cb16e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac HC
Version Model Number313-9400
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 Numbertrue
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
GS100841470107451 [Primary]
GS110841470107458 [Package]
Contains: 00841470107451
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 Date2016-10-28

On-Brand Devices [BiTrac HC]

10841470107465313-9407
10841470107731313-9109
10841470107724313-9110
10841470107717313-9111
10841470107663313-9412
10841470107649313-9415
10841470107632313-9414
10841470107625313-9413
10841470107618313-9411
10841470107601313-9410
10841470107595313-9409
10841470107588313-9408
10841470107571313-9100
10841470107564313-9101
10841470107557313-9102
10841470107540313-9103
10841470107533313-9104
10841470107496313-9404
10841470107489313-9405
10841470107472313-9406
10841470107458313-9400
10841470107441313-9403
10841470107434313-9402
10841470107427313-9401

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