BiTrac Select

GUDID 10841470104754

PULMODYNE INC

CPAP/BPAP face mask, single-use
Primary Device ID10841470104754
NIH Device Record Keyc1a1b425-8e6b-4402-bac0-4e6ba2a44187
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiTrac Select
Version Model Number313-9590
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470104757 [Primary]
GS110841470104754 [Package]
Contains: 00841470104757
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-26
Device Publish Date2018-10-26

On-Brand Devices [BiTrac Select]

10841470111691313-9602
10841470111554313-9557
10841470111547313-9558
10841470111530313-9559
10841470111097313-9524
10841470111080313-9525
10841470110922313-9527
10841470110915313-9526
10841470110625313-9593
10841470109414313-9596
10841470109391313-9594
10841470109384313-9593A
10841470109377313-9598
10841470109292313-9573
10841470108301313-9581
10841470108295313-9580
10841470108066313-9578A
10841470108059313-9577A
10841470108042313-9576A
10841470106802313-9037W
10841470106796313-9036W
10841470106789313-9035W
10841470106703313-9068W
10841470106697313-9067W
10841470106680313-9066W
10841470106550313-9048W
10841470106543313-9047W
10841470105027313-9572
10841470104983313-9576
10841470104976313-9577
10841470104952313-9578
10841470104921313-9515
10841470104914313-9543
10841470104860313-9542
10841470104853313-9501
10841470104839313-9541
10841470104754313-9590
10841470104730313-9583
10841470104723313-9582
00841470104719313-9571
10841470104679313-9563
10841470104662313-9562
10841470104655313-9561
10841470104631313-9555
10841470104624313-9554
10841470104600313-9552
10841470104549313-9533
00841470104535313-9532
10841470104525313-9531
10841470104518313-9530

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