Pulmoguard 29-7950-100

GUDID B279S297950100

S D I DIAGNOSTICS INC

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece
Primary Device IDB279S297950100
NIH Device Record Key709aecbe-d700-4c9c-8ffa-bdc10f5c7374
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmoguard
Version Model NumberI
Catalog Number29-7950-100
Company DUNS037690120
Company NameS D I DIAGNOSTICS INC
Device Count100
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB279S297950100 [Primary]
HIBCCB279S2979501002 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

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 Date2016-07-20

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B279S297930300II
B279S297930100II
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B279S297928080Pulmonary Function Test Filter
B279S297928040Pulmonary Function Test Filter
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