FitStar Hospital Nasal Non Vented Mask, s/m

GUDID 00814747023105

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

SLEEPNET, CORP.

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use

• Primary Device ID: 00814747023105
• NIH Device Record Key: 7832b341-43e7-48f5-95b3-09eb0aeb4264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FitStar Hospital Nasal Non Vented Mask, s/m
• Version Model Number: 50596
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747023105 [Primary]

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: 2022-09-22
• Device Publish Date: 2022-09-14

Devices Manufactured by SLEEPNET, CORP.

• 00814747023686 - Mojo Full Face Mask, Small with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023693 - Mojo Full Face Mask, Medium with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023709 - Mojo Full Face Mask, Large with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023716 - Mojo Full Face Mask, Extra Large with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023723 - Mojo Non Vented Full Face Mask, Small with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023730 - Mojo Non Vented Full Face Mask, Medium with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023747 - Mojo Non Vented Full Face Mask, Large with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023761 - Mojo 2 Full Face Vented Mask, Small: 2024-04-11 Full face vented mask for use in positive pressure ventilation.