ComfortGel 1070056

GUDID 00606959015395

Lifeline Systems Company

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959015395
• NIH Device Record Key: 30139377-329b-42fb-a311-896226c839ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfortGel
• Version Model Number: 00
• Catalog Number: 1070056
• Company DUNS: 080030042
• Company Name: Lifeline Systems Company
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959015395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092835

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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: 2018-08-20
• Device Publish Date: 2015-11-05

Devices Manufactured by Lifeline Systems Company

• 00884838100046 - Senior Living Personal Help Device Pendant: 2021-05-07 319PHB Senior Living Personal Help Device / Neckcord
• 00884838100053 - Senior Living Personal Help Device Wriststrap: 2021-05-07 319PHW Senior Living Personal Help Device / Wriststrap
• 00884838100060 - HomeSafe Standard Personal Help Pendant: 2021-05-07 324PHB Personal Help Buton / Neckcord
• 00884838100077 - HomeSafe Standard Personal Help Wriststrap: 2021-05-07 324PHW Personal Help Buton / Wriststrap
• 00884838100008 - GoSafe / HomeSafe Personal Help Pendant: 2021-04-12 7000PHB Personal Help Button
• 00884838100015 - Senior Living Alert Device Personal Help Pendant with Indicator: 2021-04-12 7000PHB-SL Senior Living Help Button with Indicator
• 00884838100022 - GoSafe / HomeSafe Personal Help Wriststrap: 2021-04-12 7000PHW Personal Help Wriststrap
• 00884838100039 - Senior Living Alert Device Personal Help Wriststrap with Indicator: 2021-04-12 7000PHW-SL Senior Living Help Button with Indicator