FDA.reportPublic FDA data

HUMID AIR

Primary DI
00619498004720
Brand
HUMID AIR
Company
RESMED LIMITED
Model
37479
Catalog number
37479
Device description
HUMIDAIR CLEANABLE - UDI
Published
2018-09-21
Public version status
New
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498004720Direct MarkingGS10
00619498374793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498004720006194980047206194980047200619498004720
00619498374793006194983747936194983747930619498374793

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags#

DUNS number
751149311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00619498394203AIR 1139300393002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498002610NV UM FFM60647606472020-05-14
00619498002931MIRAGE QUATTRO16129161292019-01-22
00619498002948MIRAGE QUATTRO16131161312019-01-22
00619498002924QUATTRO AIR16127161272018-11-16
00619498002375QUATTRO AIR16128161282018-11-16
00619498002290MIRAGE QUATTRO16130161302018-11-16
00619498002955QUATTRO AIR16132161322018-11-16
00619498002344QUATTRO AIR16133161332018-11-16
00619498002962AIRFIT F 1016134161342018-11-16
00619498002979AIRFIT F2016135161352018-11-16
00619498002429AIRFIT F2016136161362018-11-16
00619498002986AIRFIT F2016137161372018-11-16
00619498002320MIRAGE FX16140161402018-11-16
00619498002627NV QUATTRO FX61748617482018-11-16
00619498003006AIRFIT N30i63821638212018-11-15
00619498002412AIRFIT N 1016138161382018-10-26
00619498002900AIRFIT N2016141161412018-10-26
00619498002443AIRFIT N2016142161422018-10-26

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