Premium Headgear 1059257

GUDID 00606959060364

Reduced Size Premium Headgear, International

Respironics, Inc.

Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable Anaesthesia mask strap, reusable

• Primary Device ID: 00606959060364
• NIH Device Record Key: bc10da78-664e-48f0-b7f7-425a355ab076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Headgear
• Version Model Number: 00
• Catalog Number: 1059257
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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)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 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	00606959060364 [Primary]

FDA Product Code

• BTK: STRAP, HEAD, GAS MASK

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: 2020-12-15
• Device Publish Date: 2020-12-07

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