FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM

GUDID 05030267089680

FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM ADULT

INTERSURGICAL INCORPORATED

CPAP/BPAP face mask, single-use
Primary Device ID05030267089680
NIH Device Record Keyd7d6c105-269e-47e1-b921-3c203db67210
Commercial Distribution StatusIn Commercial Distribution
Brand NameFACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM
Version Model Number2251000
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 Usefalse
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
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
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
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267080731 [Primary]
GS105030267089680 [Package]
Contains: 05030267080731
Package: [12 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 Date2021-10-14
Device Publish Date2021-10-06

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