DreamStation 2 BLX420H15C

GUDID 00606959062825

DreamStation 2 Advanced CPAP with humidifier, cellular, bluetooth for BL

Respironics, Inc.

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• Primary Device ID: 00606959062825
• NIH Device Record Key: 69c03bd1-1482-418c-9bf9-54abdcf1d20e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation 2
• Version Model Number: 00
• Catalog Number: BLX420H15C
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959062825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200480

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: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [DreamStation 2]

• 00606959062757: DreamStation 2 ADVANCED Auto CPAP device with Humidifier, Flex Features, Cellular Bluetooth Conn
• 00606959062849: DreamStation 2 CPAP with humidifier, cellular, bluetooth for BL
• 00606959062832: DreamStation 2 Auto CPAP with humidifier, cellular, bluetooth for BL
• 00606959062825: DreamStation 2 Advanced CPAP with humidifier, cellular, bluetooth for BL
• 00606959062818: DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BL
• 00606959063099: DreamStation2 Auto CPAP Advanced with Hu
• 00606959063228: DreamStation 2 CPAP w/ Humidifier/Cell/B
• 00606959063082: DreamStation 2 Auto CPAP Advanced w/ Hum