Alice 6 1063311

GUDID 00606959006065

Alice 6, Base Station System, LDE, North America

Respironics, Inc.

Polysomnograph

• Primary Device ID: 00606959006065
• NIH Device Record Key: f9fa65b2-351d-44d7-8b51-b279f5065bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alice 6
• Version Model Number: 1068723
• Catalog Number: 1063311
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: +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
• 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
• 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
• 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
• 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
• 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
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00606959006065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040595

FDA Product Code

• OLV: Standard polysomnograph with electroencephalograph

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: 2018-11-12
• Device Publish Date: 2016-09-18

On-Brand Devices [Alice 6]

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• 00606959020696: Alice 6, Base Station System, LDE, International
• 00606959009844: Alice 6 polysomnography system Pressure Sensor, International version
• 00606959006089: Alice 6 LDx polysomnography system, (Alice 5 to 6 conversion/changeover kit), U.S./North America
• 00606959006072: Alice 6 LDE CNV Changeover Kit, North America
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• 00606959006041: Alice 6, LDE Headbox, North America
• 00606959006034: Alice 6, LDxN Headbox, North America
• 00606959004764: Alice 6 Pressure Sensor, Domestic
• 00606959004214: Alice 6 Polysomnography System LDxS Sensor Headbox, North America
• 00606959004207: Alice 6, Base Station System, LDx, North America
• 00606959047136: Alice 6 Polysomnography System LDx Base Station with Masimo Oximetry, International unit
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• 00606959047105: Alice 6 Base Station, LDE, Domestic, with Masimo
• 00606959039711: Alice 6 ConversionUpgrade, LDx, International
• 00606959038783: Alice 6, Accessory, Sensor Kit, Infant, INTERNATIONAL
• 00606959038776: Alice 6, Accessory, Sensor Kit, Adult, INTERNATIONAL
• 00606959037496: Alice 6 Communications Cable
• 00606959033764: Alice 6, Base Station System, LDx, Japan
• 00606959033757: Alice 6, Base Station System, LDE, Japan
• 00606959033740: Assembly, Alice 6 Base Station, LDx, China
• 00606959033733: Assembly, Alice 6 Base Station, LDx, Brazil
• 00606959033726: Assembly, Alice 6 Base Station, LDE, China
• 00606959033719: Assembly, Alice 6 Base Station, LDE, Brazil
• 00606959033245: Alice 6 Therapy Circuit Interface Kit
• 00606959028784: Alice 6 LDxS Headbox, China
• 00606959028777: Alice 6 LDE Headbox, China
• 00606959028760: Alice 6 LDxS Headbox, Brazil
• 00606959028753: Alice 6 LDE Headbox, Brazil
• 00606959028746: Alice 6 LDxN Headbox, Brazil
• 00606959028739: Alice 6 LDxN Headbox, China
• 00606959028722: Final Assembly, Alice 6 LDxS Headbox, China
• 00606959028715: Final Assembly, Alice 6 LDxS Headbox, International
• 00606959028708: Final Assembly, Alice 6 LDxS Headbox, Domestic
• 00606959028692: Final Assembly, Alice 6 LDE Headbox, China
• 00606959028685: Final Assembly, Alice 6 LDE Headbox, - International
• 00606959028678: Final Assembly, Alice 6 LDE Headbox - Domestic
• 00606959028661: Final Assembly, Alice 6 LDxN Headbox, China
• 00606959028623: Final Assembly, Alice 6 LDxN Headbox, International
• 00606959028609: Alice 6 LDxN Headbox, Domestic
• 00606959027749: Assembly, Alice 6 Base Station, LDx, International
• 00606959027732: Assembly, Alice 6 Base Station, LDx, Domestic
• 00606959027725: Alice 6, Base Station, LDE, International
• 00606959027718: Alice 6 Base Station, LDE, Domestic
• 00606959027145: Alice 6, Base Warranty RP, LDE, International
• 00606959027138: Alice 6, Base Warranty RP, LDE, North America
• 00606959027121: Alice 6, Base, Warranty RP, LDx, International