DreamStation AVAPS VTX1130S24

GUDID 00606959046931

DreamStation BiPAP AVAPS 30, VT

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959046931
• NIH Device Record Key: 605968a5-a366-44ae-b45e-a09dc9ccddad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation AVAPS
• Version Model Number: 00
• Catalog Number: VTX1130S24
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)744-2500
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)744-2500
• Email: RESPIRONICS.SERVICE@PHILIPS.COM

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959046931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102465

FDA Product Code

• MNS: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-18

On-Brand Devices [DreamStation AVAPS]

• 00606959048409: DreamStation AVAPS 30 with Heated Humidifier, Great Britain
• 00606959046931: DreamStation BiPAP AVAPS 30, VT
• 00606959046894: DreamStation BiPAP AVAPS 30, SA
• 00606959046870: DreamStation BiPAP AVAPS 30, MD
• 00606959046856: DreamStation BiPAP AVAPS 30, LD
• 00606959045781: DreamStation BiPAP AVAPS30 AE wHumid wCell, Australia
• 00606959045774: DreamStation BiPAP AVAPS30 AE wHumd wheated tube wCell, Australia
• 00606959045750: DreamStation BiPAP AVAPS30 AE wHumid wHeatd Tube wWiFi, Australia
• 00606959045743: DreamStation BiPAP AVAPS30 AE wHumid wWiFi, Australia
• 00606959045736: DreamStation BiPAP AVAPS30 AE wWiFi, Australia
• 00606959045729: DreamStation BiPAP AVAPS30 wHumid wHeated Tube wCell, Canada
• 00606959045712: DreamStation BiPAP AVAPS30 wHumid wCell, Canada
• 00606959045705: DreamStation AVAPS30 wCell, Canada
• 00606959045699: DreamStation AVAPS30 wHumid wHeated Tube wWiFI, Canada