NUANCE PRO 1133513

GUDID 00606959046726

NUANCE PRO GEL PLW Mask, W HGR, CN

Respironics, Inc.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959046726
• NIH Device Record Key: d8ce6f65-bcc3-4935-94f9-dca25039afd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUANCE PRO
• Version Model Number: 00
• Catalog Number: 1133513
• 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: 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
• 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
• 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 Celsius and 140 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959046726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122847

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: 2018-11-12
• Device Publish Date: 2017-11-15

On-Brand Devices [NUANCE PRO]

• 00606959021471: NUANCE PRO GEL Pillows Mask, W HGR, INTL
• 00606959014428: NUANCE PRO GEL PLW Mask, WO HGR, DOM
• 00606959012936: NUANCE PRO GEL Pillows Mask, W HGR, DOM
• 00606959046726: NUANCE PRO GEL PLW Mask, W HGR, CN
• 00606959041899: L, NUANCE PRO GEL Pillows Mask, WO HGR, DOM
• 00606959041882: M, NUANCE PRO GEL Pillows Mask, WO Headgear, DOM
• 00606959041875: S, NUANCE PRO GEL Pillows Mask, WO HGR, DOM
• 00606959041868: NUANCE PRO GEL Pillows Mask, W HGR, JPN
• 00606959041851: NUANCE PRO GEL Mask Headgear, NO CUSH, INTL
• 00606959040281: NUANCE PRO GEL Pillows Mask, W HGR, LAB