DreamStation Humidifier, INTL INXH

GUDID 00606959061040

DreamStation Humidifier, International

Respironics, Inc.

Heated respiratory humidifier

• Primary Device ID: 00606959061040
• NIH Device Record Key: 16779b37-615e-4757-8808-a322b7538c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation Humidifier, INTL
• Version Model Number: 00
• Catalog Number: INXH
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959061040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131982

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

Devices Manufactured by Respironics, Inc.

• 00606959424852 - DreamStation BiPAP autoSV: 2025-08-12 DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia
• 00606959424944 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia
• 00606959424951 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia
• 00606959424968 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
• 00606959424975 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia
• 00606959424982 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with WiFi, Australia
• 00606959424999 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
• 00606959425378 - DreamStation: 2025-08-12 DreamStation BiPAP AVAPS 30 AAM with Humidifier and Heated Tube, no Bluetooth, China