MiniMe Pediatric Mask with Headgear, Size Large

GUDID 00814747024638

Pediatric nasal vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00814747024638
• NIH Device Record Key: a1389372-f60c-4e18-a5aa-8ad0d7f437c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniMe Pediatric Mask with Headgear, Size Large
• Version Model Number: 60215
• Company DUNS: 785635186
• Company Name: SLEEPNET, CORP.
• 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: 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 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747023044 [Previous]
GS1	00814747024638 [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: 2025-05-14
• Device Publish Date: 2025-05-06

On-Brand Devices [MiniMe Pediatric Mask with Headgear, Size Large]

• 00814747020906: Pediatric nasal vented mask for use in positive pressure ventilation.
• 00814747023044: Pediatric nasal vented mask for use in positive pressure ventilation.
• 00814747024638: Pediatric nasal vented mask for use in positive pressure ventilation.