Nebulizing Elbow 1119028

GUDID 30606959007834

EE Nebulizing Elbow Kit, Single

Respironics, Inc.

CPAP/BPAP face mask, single-use

• Primary Device ID: 30606959007834
• NIH Device Record Key: c85b5c57-ce9a-4c43-b832-df5e9622c15c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebulizing Elbow
• Version Model Number: 00
• Catalog Number: 1119028
• 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)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 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 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959007833 [Primary]
GS1	30606959007834 [Package]; Contains: 00606959007833; Package: Multipack [5 Units]; Discontinued: 1999-12-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102240

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

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: 2018-07-06
• Device Publish Date: 2016-09-18

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