Pulmoguard F0606-050

GUDID B279F06060501

filter

S D I DIAGNOSTICS INC

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece
Primary Device IDB279F06060501
NIH Device Record Key34e75b72-0c3b-4a67-a170-bcbbb69bd2e7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmoguard
Version Model NumberC
Catalog NumberF0606-050
Company DUNS037690120
Company NameS D I DIAGNOSTICS INC
Device Count50
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 Batchfalse
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
HIBCCB279F0606050 [Primary]
HIBCCB279F0606050 [Primary]
HIBCCB279F0606050 [Primary]
HIBCCB279F0606050 [Primary]
HIBCCB279F06060501 [Unit of Use]
HIBCCB279F06060501 [Unit of Use]
HIBCCB279F06060501 [Unit of Use]
HIBCCB279F06060501 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit
CAHFilter, Bacterial, Breathing-Circuit
CAHFilter, Bacterial, Breathing-Circuit
CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

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