AQUESURE FILTER HUMIDIFIER OL-040419-U00

GUDID 20629160012605

Breathing circuit filter with built-in humidification

BOMImed Inc

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID20629160012605
NIH Device Record Keyb4d71bda-ca8e-4265-9b25-9834a7f581f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQUESURE FILTER HUMIDIFIER
Version Model NumberOL-040419-U00
Catalog NumberOL-040419-U00
Company DUNS248200149
Company NameBOMImed 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com
Phone800-667-6276
Emailinfo@bomimed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry area away from direct light

Device Identifiers

Device Issuing AgencyDevice ID
GS110629160012608 [Primary]
GS120629160012605 [Package]
Contains: 10629160012608
Package: box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-28
Device Publish Date2016-09-26

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20629160012605 - AQUESURE FILTER HUMIDIFIER2019-05-28Breathing circuit filter with built-in humidification
20629160012605 - AQUESURE FILTER HUMIDIFIER2019-05-28 Breathing circuit filter with built-in humidification

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