O2asis Humidifier

GUDID 00840106905447

O2asis Cannula Adult Replacement consumable for the O2asis Humidifier

PERMA PURE LLC

Heated respiratory humidifier
Primary Device ID00840106905447
NIH Device Record Key4b7e79e0-62c1-4dd7-82c0-01a128a87448
Commercial Distribution StatusIn Commercial Distribution
Brand NameO2asis Humidifier
Version Model NumberO2asis Cannula Adult
Company DUNS063142533
Company NamePERMA PURE LLC
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com
Phone866-334-2447
Emailpermapureqc@permapure.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810020360721 [Package]
Package: Inner Pack [2 Units]
In Commercial Distribution
GS100810020360806 [Package]
Package: Inner Pack [5 Units]
In Commercial Distribution
GS100840106905447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

On-Brand Devices [O2asis Humidifier]

00810020360813O2asis Pediatric Cannula Consumable of O2asis Humidifier
00840106905492O2asis Humidifier Kit
10840106905475O2asis Humidifier Base Unit
00840106905461O2asis Humidifier Water Well
00810020360745O2asis Humidifier Water Pump
00840106905447O2asis Cannula Adult Replacement consumable for the O2asis Humidifier

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