FDA.reportPublic FDA data

HA01

Primary DI
07321822110160
Brand
HA01
Company
Breas Medical AB
Model
US
Catalog number
003530
Device description
Respiratory Gas Humidifier
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07321822110160PackageGS11In Commercial Distribution
07321820035304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07321822110160073218221101607321822110160
07321820035304073218200353047321820035304

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
+4631868860techsupport@breas.com

Regulatory Flags#

DUNS number
357007657
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07321820048915Vivo 500048910048912022-06-18
07321820048922Vivo 500048920048922022-06-18
07321820048939Vivo 500048930048932022-06-18
07321820048946Vivo 500048940048942022-06-18
07321820048960Vivo 500048960048962022-06-18
07321820048977Vivo 500048970048972022-06-18
07321820048984Vivo 500048980048982022-06-18
07321820050369Vivo 500050360050362022-06-18
07321820050949Vivo 500050940050942022-06-18
07321820052233Vivo 500052230052232022-06-18
07321820059287Vivo 500059280059282022-06-18
07321822320002Clearo2320002320002026-02-17
07321820104666Clearo Patient Circuit Americas0104660104662025-11-03
05060405720083Clearo2320002320002025-11-03
07321820081691Clearo0081690081692025-11-03
07321820082834Clearo0082830082832025-11-03
07321820090655Clearo0090650090652025-11-03
07321820090662Clearo0090660090662025-11-03
07321820090679Clearo0090670090672025-11-03
07321820106226Clearo Patient Circuit Americas0104660104662025-11-03

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Primary DI, Brand, Company table
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09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
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10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
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10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344009824HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
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09420012476555F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
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09420012476593F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012477910F&P Optiflow THRIVEFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
10193489149302HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
10193489149562HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
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09420012474155Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-04-30