WISP 1101552

GUDID 00606959039919

L Wisp Mask, Clear Frame, wo Headgear, DOM

Respironics, Inc.

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

• Primary Device ID: 00606959039919
• NIH Device Record Key: 7ccd6f0b-54ac-412f-b6b5-b5698bc10d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WISP
• Version Model Number: 00
• Catalog Number: 1101552
• 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 -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 -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	00606959039919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121631

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: 2016-09-19

On-Brand Devices [WISP]

• 00606959021280: WISP MASK, CLEAR FRAME, wHeadgear, INTL SE
• 00606959021273: WISP MASK, FABRIC FRAME, W HDGR, INTL
• 00606959021266: WISP MASK, CLEAR FRAME, W HDGR, INTL
• 00606959012912: WISP MASK, FABRIC FRAME, WO HDGR, DOM
• 00606959012905: WISP MASK, CLEAR FRAME, WO HDGR, DOM
• 00606959006836: Wisp Mask, Clear Frame, wHeadgear, DOM
• 00606959006829: WISP MASK, FABRIC FRAME, W HDGR, DOM
• 00606959040175: WISP MASK, FABRIC FRAME, wHeadgear, CHN
• 00606959040168: WISP MASK, CLEAR FRAME, wHeadgear, CHN
• 00606959040151: XL WISP MASK, FABRIC FRAME, wHeadgear, JPN
• 00606959040144: L WISP MASK, FABRIC FRAME, wHeadgear, JPN
• 00606959040137: MW WISP MASK, FABRIC FRAME, wHeadgear, JPN
• 00606959040120: S,M WISP MASK, FABRIC FRAME, wHeadgear, JPN
• 00606959040113: P WISP MASK, FABRIC FRAME, wHeadgear, JPN
• 00606959040106: WISP MASK, CLEAR FRAME, wHeadgear, CHN SE
• 00606959040090: WISP MASK, CLEAR FRAME, wHeadgear, JPN SE
• 00606959040083: XL Wisp Mask, Fabric Frame, wHeadgear, INTL
• 00606959040076: L Wisp Mask, Fabric Frame, wHeadgear, INTL
• 00606959040069: S,M Wisp Mask, Fabric Frame, wHeadgear, INTL
• 00606959040052: P Wisp Mask, Fabric Frame, wHeadgear, INTL
• 00606959040045: XL Wisp Mask, Clear Frame, wHeadgear, INTL
• 00606959040038: L Wisp Mask, Clear Frame, wHeadgear, INTL
• 00606959040021: S,M Wisp Mask, Clear Frame, wHeadgear, INTL
• 00606959040014: P Wisp Mask, Clear Frame, wHeadgear, INTL
• 00606959040007: Wisp Youth Mask, Fabric Frame, wHeadgear, CHN
• 00606959039995: Wisp Youth Mask, Fabric Frame, wHeadgear, INTL
• 00606959039988: Wisp Youth Mask, Fabric Frame, wo Headgear, DOM
• 00606959039971: Wisp Youth Mask, Fabric Frame, wHeadgear, DOM
• 00606959039964: XL Wisp Mask, Fabric Frame, wo Headgear, DOM
• 00606959039957: L Wisp Mask, Fabric Frame, wo Headgear, DOM
• 00606959039933: P Wisp Mask, Fabric Frame, wo Headgear, DOM
• 00606959039926: XL Wisp Mask, Clear Frame, wo Headgear, DOM
• 00606959039919: L Wisp Mask, Clear Frame, wo Headgear, DOM
• 00606959039902: SM Wisp Mask, Clear Frame, wo Headgear, DOM
• 00606959039896: P Wisp Mask, Clear Frame, wo Headgear, DOM
• 00606959037380: Wisp Mask, USA, Fabric Frame, wHeadgear, DOM
• 00606959051874: Wisp Mask, Clear Frame with Headgear, Small-Medium, USA
• 00606959050518: Wisp Nasal Lab Mask, Clear Frame, Large, USA
• 00606959050501: Wisp Nasal Lab Mask, Clear Frame, Small-Medium, USA
• 00606959050495: Wisp Nasal Lab Mask, Fabric Frame, Large, USA
• 00606959050471: Wisp Nasal Lab Mask, Combopack, USA
• 00606959050464: Wisp Nasal Lab Mask, Clear Frame, USA
• 00606959050457: Wisp Nasal Lab Mask, Fabric Frame, USA
• 00606959051928: Wisp Mask, Fabric Frame with Headgear, Large, USA
• 00606959051911: Wisp Mask, Fabric Frame with Headgear, Small Medium, USA
• 00606959051904: Wisp Mask, Fabric Frame with Headgear, Petite, USA
• 00606959051898: Wisp Mask, Clear Frame with Headgear, X-Large, USA
• 00606959051881: Wisp Mask, Clear Frame with Headgear, Large, USA
• 00606959051867: Wisp Mask, Clear Frame with Headgear, Petite, USA
• 00606959039698: WispDreamWisp Magnetic Clips, Replacement Part