galemed Disposable Humidification Chamber - Auto feeding (

GUDID 44710810087392

GALEMED CORPORATION

Ventilator IMV supplemental circuit, reusable

• Primary Device ID: 44710810087392
• NIH Device Record Key: ef33582a-25d3-42fa-93d3-1654a6172248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: galemed
• Version Model Number: 38023
• Catalog Number: Disposable Humidification Chamber - Auto feeding (
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810087394 [Primary]
GS1	44710810087392 [Package]; Contains: 04710810087394; Package: Carton [50 Units]; In Commercial Distribution

FDA Product Code

• BZO: Set, Tubing And Support, Ventilator (W Harness)

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