Performax 1119145

GUDID 30606959013019

PerforMax Full Face Mask - EE (Leak 2 elbow), China

Respironics, Inc.

CPAP/BPAP face mask, single-use

• Primary Device ID: 30606959013019
• NIH Device Record Key: 73c986e3-5bc3-4eca-a027-9a48b7bc0a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performax
• Version Model Number: 00
• Catalog Number: 1119145
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com
• Phone: +1 724-387-4000
• Email: Respironics.Service@Philips.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959013018 [Primary]
GS1	30606959013019 [Package]; Contains: 00606959013018; Package: Multipack [5 Units]; Discontinued: 1999-12-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091271

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-26

On-Brand Devices [Performax]

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• 00606959013704: Performax MPU China with EE Leak 2, Plus 4HG, Large
• 00606959013698: Performax MPU China with EE Leak 2, Plus 4HG, Small
• 00606959013667: PerforMax China SE Elbow Kit, Single
• 30606959013019: PerforMax Full Face Mask - EE (Leak 2 elbow), China
• 30606959013002: Performax SU China with SE, Large
• 30606959012999: Performax SU China with SE, Small
• 30606959012982: Performax SU China with EE Leak 2, Large
• 30606959012975: Performax SU China with EE Leak 2, Small
• 30606959011992: PerforMax SPU SE SA, XLarge
• 30606959011985: PerforMax SPU EE SA, XLarge
• 00606959011977: PerforMax MPU with SE, Plus 4HG, International, XLarge
• 00606959011960: PerforMax MPU with EE Leak 2, Plus 4HG, International, XLarge
• 00606959011953: PerforMax MPU with EE Leak 2 and SE, Plus 4HG, XLarge
• 00606959011946: PerforMax MPU with EE Leak 2, Domestic, XLarge
• 00606959011915: Performax MPU with SE, Plus 4HG, International, Large
• 00606959011908: Performax MPU with SE, Plus 4HG, International, Small
• 00606959011892: PerforMax MPU with EE Leak 2, Plus 4HG, International, Large
• 00606959011885: PerforMax MPU with EE Leak 2, Plus 4HG, International, Small
• 30606959011879: PerforMax Disposable SE SA, Japan, Large
• 30606959011862: PerforMax Disposable SE SA, Japan, Small
• 30606959011855: PerforMax SPU EE SA, Japan, Large
• 30606959011848: PerforMax SPU EE SA, Japan, Small
• 30606959011831: PerforMax SPU SE SA, Domestic, Large
• 30606959011824: PerforMax SPU SE SA, Domestic, Small
• 00606959011786: Performax MPU with EE Leak 2, Domestic, Large
• 00606959008021: PERFORMAX MPU WITH EE LEAK 2 AND SE, XLarge
• 00606959008014: PerforMax MPU with EE Leak 2 and SE, Plus 4HG, International, Large
• 00606959008007: PerforMax MPU with EE Leak 2 and SE, Plus 4HG, International, Small
• 00606959007994: Performax MPU with EE Leak 2 and SE, International, Large
• 00606959007987: Performax MPU with EE Leak 2 and SE, International, Small
• 00606959007727: PerforMax SU with SE - Single, XLarge
• 00606959007710: Performax SU with SE - Single, Large
• 00606959007703: Performax SU with SE - Single, Small
• 00606959007697: PerforMax SU with EE Leak 2 -Single, XLarge
• 00606959004160: Performax SU with EE Leak 2 - Single, Large
• 00606959004153: Performax SU with EE Leak 2 - Single, Small
• 30606959004086: PerforMax SPU EE SA, Domestic, Large
• 30606959004079: PerforMax SPU EE SA, Domestic, Small
• 00606959003866: Performax MPU with EE Leak 2, Domestic, Small
• 30606959000880: PerforMax SPU SE SA, International, Large
• 30606959000873: PerforMax SPU SE SA, International, Small
• 30606959000866: PerforMax SPU EE SA, International, Large
• 30606959000859: PerforMax SPU EE SA, International, Small
• 00606959000766: Performax MPU with EE Leak 2 and SE, Domestic, Large
• 00606959000759: Performax MPU with EE Leak 2 and SE, Domestic, Small
• 00606959042537: Philips EE Starter Kit, Base Kit and PerforMax, MultiUse, 4- Headgear
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• 30606959042453: Philips Procedure, PerforMax with Filtered Exhalation Port, Small, SA