FDA.reportPublic FDA data

O2asis Humidifier

Primary DI
00840106905447
Brand
O2asis Humidifier
Company
PERMA PURE LLC
Model
O2asis Cannula Adult
Device description
O2asis Cannula AdultReplacement consumable for the O2asis Humidifier
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193411000O2asis Personal Oxygen HumidifierPerma Pure, LLC2020-11-12BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810020360721PackageGS12In Commercial Distribution
00810020360806PackageGS15In Commercial Distribution
00840106905447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020360721008100203607218100203607210810020360721
00810020360806008100203608068100203608060810020360806
00840106905447008401069054478401069054470840106905447

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-334-2447permapureqc@permapure.com

Regulatory Flags#

DUNS number
063142533
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840106906277Nafion DryerME SeriesME-050-48BB 2025-08-29
00840106906253Nafion DryerME SeriesME-050-03-2832025-05-22
10840106906250Nafion DryerME SeriesME-050-03-2832025-05-22
00840106906246Nafion DryerME SeriesME-070-03-562025-03-20
10840106906243Nafion DryerME SeriesME-070-03-562025-03-20
00840106906031PERMA PUREME SeriesME-050-03-2822024-10-15
90840106905075PERMA PUREME SeriesME-070-48BB 2024-11-12
00840106906192PERMA PUREME SeriesME-050-03-2292024-11-12
10840106906199PERMA PUREME SeriesME-050-03-2292024-11-12
90840106905082PERMA PUREME SeriesME-070-48BB 2024-11-12
00840106905157PERMA PUREME SeriesME-050-03-2732024-11-07
00840106905164PERMA PUREME SeriesME-060-24-BB2024-11-07
00840106905171PERMA PUREME SeriesME-060-03-1112024-11-07
00840106905195PERMA PUREME SeriesME-060-03-732024-11-07
00840106905201PERMA PUREME SeriesME-110-03-372024-11-07
00840106905218PERMA PUREME SeriesME-110-03-172024-11-07
00840106905560PERMA PUREME SeriesME-110-18-BB2024-11-07
00840106906086PERMA PUREME SeriesME-070-03-242024-11-07
00840106906208PERMA PUREME SeriesME-110-03-2292024-11-07
00840106906215PERMA PUREME SeriesME-070-03-262024-11-07

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