BiTrac SE Select

GUDID 10841470104556

PULMODYNE INC

CPAP/BPAP face mask, single-use
Primary Device ID10841470104556
NIH Device Record Key8e4cec5c-3705-4a20-a830-1cb22180db1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac SE Select
Version Model Number313-9535
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
GS100841470104559 [Primary]
GS110841470104556 [Package]
Contains: 00841470104559
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 Date2016-11-25

On-Brand Devices [BiTrac SE Select]

10841470111684313-9601
10841470109438313-9595
10841470109360313-9599
10841470106826313-9039W
10841470106772313-9034W
10841470106765313-9033W
10841470106758313-9032W
10841470106741313-9031W
10841470106727313-9030W
10841470106710313-9028W
10841470106673313-9064W
10841470106666313-9063W
10841470106567313-9049W
10841470106512313-9044W
10841470106482313-9041W
10841470106475313-9040W
10841470104907313-9509
10841470104891313-9546
10841470104884313-9547
10841470104877313-9548
10841470104846313-9567
10841470104808313-9597
10841470104709313-9568
10841470104686313-9566
10841470104648313-9556
10841470104617313-9553
10841470104594313-9551
10841470104587313-9538
10841470104570313-9537
10841470104563313-9536
10841470104556313-9535
10841470104464313-9508
10841470104457313-9507
10841470104440313-9506
10841470106659313-9062W
10841470106499313-9042W
10841470106505313-9043W

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