galemed Disposable Humidification Chamber - Auto feeding (

GUDID 44710810111240

GALEMED CORPORATION

Heated respiratory humidifier

• Primary Device ID: 44710810111240
• NIH Device Record Key: b298be80-5341-448d-9694-21c5bc44b680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: galemed
• Version Model Number: 3426
• Catalog Number: Disposable Humidification Chamber - Auto feeding (
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	44710810111240 [Primary]
GS1	94710810111245 [Unit of Use]

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-15

On-Brand Devices [galemed]

• 44710810117129: 3431
• 44710810087392: 38023
• 44710810111240: 3426
• 64710810116966: SP01
• 64710810116461: SP02
• 64710810115990: SP03
• 44710810089440: 8581G