PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE

GUDID 05030267161027

PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE

Intersurgical Incorporated

Pulmonary function testing filter/mouthpiece
Primary Device ID05030267161027
NIH Device Record Key9a6cd36d-f725-4ce4-a109-78bbe99a53fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
Version Model Number1691004
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267161010 [Primary]
GS105030267161027 [Package]
Contains: 05030267161010
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-15

On-Brand Devices [PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE]

05030267161027PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
05030267160648PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
05030267160594PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
05030267160570PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE

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