FDA.reportPublic FDA data

O2asis Humidifier

Primary DI
00840106905461
Brand
O2asis Humidifier
Company
PERMA PURE LLC
Model
O2asis Humidifier Water Well
Device description
O2asis Humidifier Water Well
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

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
00810020360738PackageGS11In Commercial Distribution
00840106905461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020360738008100203607388100203607380810020360738
00840106905461008401069054618401069054610840106905461

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

Regulatory Flags#

DUNS number
063142533
Device count
1
Lot or batch
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012474643F&P 850FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-13
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012430410Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012449818Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012465849Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012471918Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012481740F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481795F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344005994HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344029693HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-14
10197344029730HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-14
10197344009824HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009855HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009862HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009879HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344029709HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344029716HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344029723HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009589HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009848HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344011025HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344011056HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009817HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-04-05
10197344009831HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-03-24
10193489149296HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-11-22