DreamWear 1146466

GUDID 00606959060920

DreamWear Dm Plw, Combo Pack, Lab

Respironics, Inc.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959060920
• NIH Device Record Key: a35c8cd2-251e-4f6d-9371-6ddac1583dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamWear
• Version Model Number: 00
• Catalog Number: 1146466
• 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

Operating and Storage Conditions

• 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	00606959060920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140980

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [DreamWear]

• 00606959023116: 00
• 00606959022980: 00
• 00606959022324: 00
• 00606959052291: DreamWear SC UTN Fitpack Japan
• 00606959052062: DreamWear UTN Nasal, Fitpack WHGR, USA
• 00606959049765: DreamWear Gel Pillows, Starter Pack, INTL
• 00606959049642: DreamWear Under the Nose Nasal, Medium Frame w Hgr, Korea
• 00606959049383: Medium Wide, DreamWear Full, Small and Medium Frame, Korea
• 00606959049376: Small Wide, DreamWear Full, Small and Medium Frame, Korea
• 00606959049369: 00
• 00606959049352: Small, DreamWear Full, Small and Medium Frame, Korea
• 00606959048898: DreamWear Under the Nose Nasal, Large Frame WHGR, CHN
• 00606959048881: DreamWear Under the Nose Nasal, Medium Frame WHGR, CHN
• 00606959048874: DreamWear Under the Nose Nasal, Small Frame WHGR, CHN
• 00606959040496: S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
• 00606959040489: S-M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
• 00606959040472: S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
• 00606959040342: DreamWear Under the Nose Nasal Mask, Wide Cushion, Medium Frame wHeadgear, Japan
• 00606959040335: M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
• 00606959040328: DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
• 00606959040311: W DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
• 00606959040304: M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
• 00606959040298: W DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
• 00606959040274: M DreamWear Under the Nose, Sm Frame wHeadgear, JPN
• 00606959037670: S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
• 00606959037656: S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
• 00606959037571: DreamWear Under the Nose Nasal, Med Frame wHeadgear, INTL
• 00606959037564: DreamWear Under the Nose Nasal, Fitpack, INTL
• 00606959031135: MW DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
• 00606959031128: L DreamWear Under the Nose Nasal, Large Frame WO Headgear, GBL
• 00606959031111: M DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
• 00606959031104: S DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
• 00606959031098: MW DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL
• 00606959031081: L DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL
• 00606959031074: M DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL
• 00606959031067: S DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL
• 00606959031050: MW DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
• 00606959031043: L DreamWear Under the Nose Nasal, Med Frame WO HGR, GBL
• 00606959031036: M DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
• 00606959030961: S DreamWear Under the Nose, Med Frame WO Headgear, GBL
• 00606959030947: DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
• 00606959030916: DreamWear Under the Nose Nasal, Med Frame wHeadgear, GBL
• 00606959030909: DreamWear Under the Nose Nasal, FitPack
• 00606959030893: MW DreamWear Under the Nose, Lg Frame wHeadgear, GBL
• 00606959030886: L DreamWear Under the Nose, Lg Frame wHeadgear, GBL
• 00606959030879: M DreamWear Under the Nose, Lg Frame wHeadgear, GBL
• 00606959030862: S DreamWear Under the Nose, Large Frame wHeadgear, GBL
• 00606959030855: MW DreamWear Under the Nose, Sm Frame wHeadgear, GBL
• 00606959030848: L DreamWear Under the Nose, Sm Frame wHeadgear, GBL
• 00606959030824: M DreamWear Under the Nose, Sm Frame wHeadgear, GBL