Plateau Exhalation Valve 302312

GUDID 00606959020177

PEV Single, ReUSAble

Respironics, Inc.

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• Primary Device ID: 00606959020177
• NIH Device Record Key: 05e9791e-130c-4c81-9ff4-dba6686dd964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau Exhalation Valve
• Version Model Number: 302312
• Catalog Number: 302312
• 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: false
• 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
• 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
• 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
• 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

• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959020177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962203

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: 2020-06-01
• Device Publish Date: 2020-05-22

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