FDA.report

Airlife™ Sterile Water for Inhalation, USP, 500 ml

Primary DI
30889483571471
Brand
Airlife™ Sterile Water for Inhalation, USP, 500 ml
Company
Sunmed Group Holdings, LLC
Model
002620
Catalog number
002620
Device description
Sterile Water for Inhalation, USP, 500 ml
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483571471PackageGS112In Commercial Distribution
10190752141643PreviousGS10
10889483571477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948357147130889483571471
1019075214164310190752141643
1088948357147710889483571477

GMDN Terms

TermDefinition
Non-heated respiratory humidifierA device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
119058668
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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