Utopia AV UTO251

GUDID 00833224000309

Utopia AV Full Face Mask - SM

Innomed Technologies Inc

CPAP/BPAP face mask, single-use
Primary Device ID00833224000309
NIH Device Record Key51d8c9c7-8b80-4b51-9846-f9a782556b7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUtopia AV
Version Model NumberUTO251
Catalog NumberUTO251
Company DUNS103307950
Company NameInnomed Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-200-9842
Emailcustomerservice@innomedinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100833224000309 [Primary]
GS150833224000304 [Package]
Package: [30 Units]
In Commercial Distribution
HIBCCM694UTO2511 [Secondary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

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 Date2016-09-15

On-Brand Devices [Utopia AV]

00833224001047Utopia AV Full Face Mask - LG (with Black Headgear)
00833224001030Utopia AV Full Face Mask - MD (with Black Headgear)
00833224001023Utopia AV Full Face Mask - SM (with Black Headgear)
00833224000323Utopia AV Full Face Mask - LG
00833224000316Utopia AV Full Face Mask - MD
00833224000309Utopia AV Full Face Mask - SM

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