iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear

GUDID 00814747020777

Nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhalation valves.

SLEEPNET, CORP.

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• Primary Device ID: 00814747020777
• NIH Device Record Key: 1f6956a8-ebb3-4c9f-9e2a-248c3b14340c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear
• Version Model Number: 50575
• Company DUNS: 785635186
• Company Name: SLEEPNET, CORP.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747020777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102317

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2016-06-07

On-Brand Devices [iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear]

• 00814747020777: Nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhalation valves
• 00814747022894: Nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhalation valves