BiTrac

GUDID 10841470106444

PULMODYNE INC

CPAP/BPAP nasal mask, single-use
Primary Device ID10841470106444
NIH Device Record Key166bc91b-3129-4e46-a7ec-b01fed6caa49
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac
Version Model Number313-9013W
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
GS100841470106447 [Primary]
GS110841470106444 [Package]
Contains: 00841470106447
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 Date2016-10-14

On-Brand Devices [BiTrac]

10841470108165313-9075
10841470108158313-9074
10841470108134313-9076
00841470108120313-9073
00841470108113313-9072
00841470108106313-9071
10841470108097313-9070
10841470109421313-9085
10841470107977313-9616
10841470107960313-9615
10841470107946313-9614
10841470107939313-9613
10841470107168313-9008
10841470107151313-9007
10841470107144313-9006
10841470107120313-9005
10841470107007313-9015W
10841470106468313-9016W
10841470106451313-9014W
10841470106444313-9013W
10841470106390313-9004W
10841470106383313-9003W
10841470106376313-9002W
10841470106369313-9001W

Trademark Results [BiTrac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BITRAC
BITRAC
90533714 not registered Live/Pending
Engineered Medical Systems, Inc.
2021-02-18
BITRAC
BITRAC
73374651 1241949 Dead/Cancelled
Transducer Systems, Inc.
1982-07-14

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