DreamWear Full 1133411

GUDID 00606959045965

M, DreamWear Full, Sm Frm WO HGR, GBL

Respironics California, Inc.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959045965
• NIH Device Record Key: 82d4daea-cb6d-4361-8269-620812dabb67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamWear Full
• Version Model Number: 00
• Catalog Number: 1133411
• Company DUNS: 079550876
• Company Name: Respironics California, 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959045965 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-13

Devices Manufactured by Respironics California, Inc.

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• 00884838009868 - PHILIPS: 2020-09-30 V60 Ventilator, Intl Opt: None
• 00884838015722 - PHILIPS: 2020-09-30 Cfgkit,V60,DISS,Grn,Ff,Cord:Schuko
• 00884838015739 - PHILIPS: 2020-09-30 Cfgkit,V60,NIST,Wht,Ff,Cord:UK
• 00884838015753 - PHILIPS: 2020-09-30 Cfgkit,V60,NIST/Afnor,Wht,Fm,Cord:Schuko
• 00884838015791 - PHILIPS: 2020-09-30 Cfgkit,V60,DISS,Grn,Ff,Cord:UK
• 00884838015807 - PHILIPS: 2020-09-30 Cfgkit,V60,NIST,Wht,Ff,Cord:SchUKo