810 Respiratory Humidifier MR810AEK

GUDID 09420012411822

Heated respiratory humidifier Power input 200 VA Heater plate 150 W Heater wire 30 W

FISHER & PAYKEL HEALTHCARE LIMITED

Heated respiratory humidifier

• Primary Device ID: 09420012411822
• NIH Device Record Key: a5d3e241-8e0d-4398-9437-1211066879bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 810 Respiratory Humidifier
• Version Model Number: MR810AEK
• Catalog Number: MR810AEK
• Company DUNS: 590153276
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012411822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131957

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: 4
• Public Version Date: 2026-03-11
• Device Publish Date: 2016-09-08

On-Brand Devices [810 Respiratory Humidifier]

• 09420012430168: Heated respiratory humidifier Power input 200 VA Heater plate 150 W Heater wire 30 W
• 09420012411891: Heated respiratory humidifier Power input 200 VA Heater plate 150 W Heater wire 30 W
• 09420012411822: Heated respiratory humidifier Power input 200 VA Heater plate 150 W Heater wire 30 W