AMARA 1090267

GUDID 00606959013902

Amara FitPack

Respironics, Inc.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00606959013902
• NIH Device Record Key: 5b6ca375-3365-49b6-b711-51d4e8c58b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMARA
• Version Model Number: 00
• Catalog Number: 1090267
• 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

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 -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	00606959013902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082866

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: 2016-06-10

On-Brand Devices [AMARA]

• 00606959022973: 00
• 00606959022966: 00
• 00606959022959: 00
• 00606959015036: AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE
• 00606959015029: AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, MEDIUM
• 00606959015012: AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, SMALL
• 00606959015005: AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, PETITE
• 00606959014992: AMARA MASK WITH RS FRAME AND HEADGEAR INTL, LARGE
• 00606959014985: AMARA MASK WITH RS FRAME AND HEADGEAR INTL, MEDIUM
• 00606959014978: AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, SMALL
• 00606959014961: AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, PETITE
• 00606959014459: AMARA STARTER KIT, PETITE
• 00606959014374: AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, PETITE
• 00606959013902: Amara FitPack
• 00606959012899: AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, MEDIUM
• 00606959012851: AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, SMALL
• 00606959012653: AMARA MASK WITH RS FRAME AND HEADGEAR DOM, LARGE
• 00606959012646: AMARA MASK WITH RS FRAME AND HEADGEAR DOM, MEDIUM
• 00606959009325: 00
• 00606959007192: AMARA HEADGEAR - RP
• 00606959007185: AMARA HEADGEAR, RS, RP
• 00606959007154: AMARA CUSHION, RP-LARGE
• 00606959007147: AMARA CUSHION, RP-MEDIUM
• 00606959007130: AMARA CUSHION, RP - SMALL
• 00606959007123: AMARA CUSHION, RP - PETITE
• 00606959006508: AMARA MASK WITH RS FRAME AND RS HEADGEAR DOM, SMALL
• 00606959006492: AMARA MASK W RS FRAME AND RS HEADGEAR DOM, PETITE
• 00606959025219: AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, LARGE
• 00606959025202: AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, MEDIUM
• 00606959025196: AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, SMALL
• 00606959025189: AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, PETITE
• 00606959025172: AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, LARGE
• 00606959025165: AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, MEDIUM
• 00606959025158: AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, SMALL
• 00606959025141: AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, PETITE
• 00606959025134: AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, LARGE
• 00606959025127: AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, MEDIUM
• 00606959025110: AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, SMALL
• 00606959025103: AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, PETITE
• 00606959025097: AMARA MASK WITH RS FRAME AND HEADGEAR JPN, LARGE
• 00606959025080: AMARA MASK WITH RS FRAME AND HEADGEAR JPN, AMARA
• 00606959025073: AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, SMALL
• 00606959025066: AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, PETITE
• 00606959024946: AMARA STARTER KIT, LARGE
• 00606959024939: AMARA STARTER KIT, MEDIUM
• 00606959024922: AMARA STARTER KIT, SMALL
• 00606959024892: AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, LARGE
• 00606959024748: Amara View Mask with headgear, XS, Japan