Innova Hospital Nasal Non Vented Mask, s/m

GUDID 00814747020814

Disposable nasal non vented mask for use with non invasive ventilator system with exhalation valves.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use
Primary Device ID00814747020814
NIH Device Record Key5f45b17a-aa8e-470a-a19a-92f2a0397614
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnova Hospital Nasal Non Vented Mask, s/m
Version Model Number50594
Company DUNS785635186
Company NameSLEEPNET, CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747020814 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-07

On-Brand Devices [Innova Hospital Nasal Non Vented Mask, s/m]

00814747020814Disposable nasal non vented mask for use with non invasive ventilator system with exhalation val
00814747022634Disposable nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhala

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