WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10 8-100795-00

GUDID 30884838075642

RESPIRONICS NOVAMETRIX, LLC

Home CPAP unit

• Primary Device ID: 30884838075642
• NIH Device Record Key: 584aa25e-37fe-49d6-8e72-1ba871b544b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10
• Version Model Number: 00
• Catalog Number: 8-100795-00
• Company DUNS: 093608594
• Company Name: RESPIRONICS NOVAMETRIX, LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838075641 [Primary]
GS1	30884838075642 [Package]; Contains: 00884838075641; Package: Multipack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982283

FDA Product Code

• BYE: Attachment, breathing, positive end expiratory pressure

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: 2018-11-12
• Device Publish Date: 2017-09-01

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