Apnea Guard

GUDID 00850015266379

Apnea Guard Resupply Kit 5L10M20H (V2)

ADVANCED BRAIN MONITORING, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00850015266379
• NIH Device Record Key: d3ca7ea2-a7ca-489c-8fa0-abbd208d4f70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apnea Guard
• Version Model Number: AG25-1014
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015266379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111110

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2021-10-05
• Device Publish Date: 2021-09-27

On-Brand Devices [Apnea Guard]

• 00851113007147: Apnea Guard Starter Kit 2L2M1H
• 00851113007130: Apnea Guard Starter Kit 1L3M1H
• 00851113007123: Apnea Guard Retention Material Kit 5.5g
• 00851113007116: Apnea Guard Retention Material Kit 100g
• 00851113007109: Apnea Guard Retention Material Kit 200g
• 00851113007093: Apnea Guard Retention Material Kit 400g
• 00851113007086: Apnea Guard Combo Kit 2L2M1H
• 00851113007079: Apnea Guard Combo Kit 1L3M1H
• 10851113007069: Apnea Guard Device High
• 10851113007052: Apnea Guard Device Medium
• 00851113007048: Apnea Guard Device Low
• 00850015266041: Apnea Guard Starter Kit 2L2M1H (V2)
• 00850015266034: Apnea Guard Starter Kit 1L3M1H (V2)
• 00850015266027: Apnea Guard Device High (V2)
• 00850015266010: Apnea Guard Device Medium (V2)
• 00850015266003: Apnea Guard Device Low (V2)
• 00850015266065: Apnea Guard Scoop Kit (5)
• 00850015266270: Apnea Guard Starter Kit 2L2M1H (SPA)
• 00850015266263: Apnea Guard Starter Kit 1L3M1H (SPA)
• 30850015266028: Apnea Guard Device Kit High (10) Spanish (V2)
• 30850015266011: Apnea Guard Device Kit Medium (10) Spanish (V2)
• 30850015266004: Apnea Guard Device Kit Low (10) Spanish (V2)
• 20850015266021: Apnea Guard Device Kit High (10) (V2)
• 20850015266014: Apnea Guard Device Kit Medium (10) (V2)
• 20850015266007: Apnea Guard Device Kit Low (10) (V2)
• 00850015266393: Apnea Guard Starter Kit 1L2M2H Spanish (V2)
• 00850015266386: Apnea Guard Starter Kit 1L2M2H (V2)
• 00850015266379: Apnea Guard Resupply Kit 5L10M20H (V2)
• 00850015266362: Apnea Guard Starter Kit 1L3M6H (V2)
• 00850015266485: Apnea Guard Starter Kit 1L2M2H UK
• 00850015266478: Apnea Guard Starter Kit 2L2M1H UK
• 00850015266461: Apnea Guard Starter Kit 1L3M1H UK
• 00850015266454: Apnea Guard Starter Kit 1L2M2H Spanish
• 00850015266447: Apnea Guard Starter Kit 2L2M1H Spanish
• 00850015266430: Apnea Guard Starter Kit 1L3M1H Spanish
• 00850015266058: 25-5301
• 00850063034050: Apnea Guard Resupply Kit 5L10M20H (V2 OEM)
• 00850063034043: Apnea Guard Starter Kit 1L3M6H (V2 OEM)
• 00850063034036: Apnea Guard Starter Kit 1L2M2H (V2 OEM)
• 00850063034029: Apnea Guard Starter Kit 2L2M1H (V2 OEM)
• 00850063034012: Apnea Guard Starter Kit 1L3M1H (V2 OEM)
• 00850063034005: Apnea Guard Retention Material Kit 400g (OEM)