PICO CN1104940

GUDID 00606959035959

Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear, CHN

Respironics, Inc.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959035959
• NIH Device Record Key: 2428fd60-d1e7-4332-94b8-19bcadbf2d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICO
• Version Model Number: 01
• Catalog Number: CN1104940
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959035959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110405

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: 2016-09-02

On-Brand Devices [PICO]

• 00606959009127: Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear
• 00606959009110: RP Pico Traditional Nasal Mask Sizing Gauge
• 00606959009103: RP XL Pico Traditional Nasal Mask Cushion
• 00606959009097: RP L Pico Traditional Nasal Mask Cushion
• 00606959009080: RP SM Pico Traditional Nasal Cushion
• 00606959009073: RP Pico Traditional Nasal Mask RS Headgear
• 00606959009066: RP Pico Traditional Nasal Mask Headgear
• 00606959009059: RP Pico Traditional Nasal Mask Headgear Clips
• 00606959009028: Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear USA
• 00606959009011: XL Pico Traditional Nasal Mask wHeadgear, CHN
• 00606959009004: L Pico Traditional Nasal Mask wHeadgear CHN
• 00606959008991: S-M Pico Traditional Nasal Mask wHeadgear, CHN
• 00606959008984: XL PICO NASAL MASK W HGR JPN
• 00606959008977: L PICO NASAL MASK W HGR JPN
• 00606959008960: SM PICO NASAL MASK W RS HGR JPN
• 00606959008953: XL Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959008946: L Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959008939: S-M Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959008922: XL Pico Traditional Nasal Mask without Headgear
• 00606959008915: L Pico Traditional Nasal Mask without Headgear
• 00606959008908: S-M Pico Traditional Nasal Mask without Headgear
• 00606959008892: XL Pico Traditional Nasal Mask wHeadgear
• 00606959008885: L Pico Traditional Nasal Mask wHeadgear
• 00606959008878: S-M Pico Traditional Nasal Mask wHeadgear
• 00606959037649: XL Pico Traditional Nasal Mask wHeadgear, CHN
• 00606959037632: L Pico Traditional Nasal Mask wHeadgear CHN
• 00606959037625: XL Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959037618: XL Pico Traditional Nasal Mask without Headgear
• 00606959037601: L Pico Traditional Nasal Mask without Headgear
• 00606959037595: XL Pico Traditional Nasal Mask wHeadgear
• 00606959037588: Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear
• 00606959035959: Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear, CHN
• 00606959035911: Fitpack S-M, L, XL Pico Traditional Nasal Mask wHeadgear USA
• 00606959035904: S-M Pico Traditional Nasal Mask wHeadgear, CHN
• 00606959035898: L Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959035881: S-M Pico Traditional Nasal Mask wHeadgear, INTL
• 00606959035874: S-M Pico Traditional Nasal Mask without Headgear
• 00606959035867: L Pico Traditional Nasal Mask wHeadgear
• 00606959035850: S-M Pico Traditional Nasal Mask wHeadgear
• 00606959062511: Small Medium Large Extra Large Pico Fitpack with Headgear Malaysia
• 00606959062504: Extra Large Pico Nasal Mask with Headgear Malaysia
• 00606959062498: Large Pico Nasal Mask with Headgear Malaysia
• 00606959062481: Small Medium Pico Nasal Mask with Headgear Malaysia