Varifit NIV Non Vented Mask, Extra Large Adult

GUDID 00814747021323

Disposable full face non vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use

• Primary Device ID: 00814747021323
• NIH Device Record Key: eb01d055-1544-45ab-b45e-f74096a0ecc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varifit NIV Non Vented Mask, Extra Large Adult
• Version Model Number: 22790
• 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

Customer Support Contacts

• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747021293 [Primary]
GS1	00814747021323 [Package]; Contains: 00814747021293; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-23

On-Brand Devices [Varifit NIV Non Vented Mask, Extra Large Adult]

• 00814747021323: Disposable full face non vented mask for use in positive pressure ventilation.
• 00814747024584: Disposable full face non vented mask for use in positive pressure ventilation.