Hybrid AV HYB551

GUDID 50833224000267

Hybrid AV Face Mask – SM

Innomed Technologies Inc

CPAP/BPAP oral mask
Primary Device ID50833224000267
NIH Device Record Key85dafe27-8c9e-4ce6-81fa-c671db760920
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybrid AV
Version Model NumberHYB551
Catalog NumberHYB551
Company DUNS103307950
Company NameInnomed Technologies Inc
Device Count1
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100833224000262 [Primary]
GS150833224000267 [Package]
Contains: 00833224000262
Package: [30 Units]
In Commercial Distribution

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 [Hybrid AV]

50833224000267Hybrid AV Face Mask – SM
50833224000250Hybrid AV Face Mask – MD
00833224000248Hybrid AV Face Mask – LG

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