Blue EF + Hard

GUDID 00851861007116

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea.

RESPIRE MEDICAL HOLDINGS LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851861007116
• NIH Device Record Key: 9eb6fa87-03cc-45dc-b42e-0c1ca415d342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue EF + Hard
• Version Model Number: SBP030US
• Company DUNS: 059636679
• Company Name: RESPIRE MEDICAL HOLDINGS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 718-643-7326
• Email: info@respiremedical.com

Device Dimensions

• Circumference: 200 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in water when not in use

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851861007116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152292

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-17
• Device Publish Date: 2017-06-15

Devices Manufactured by RESPIRE MEDICAL HOLDINGS LLC

• 00851861007253 - Respire Pink AT EF: 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
• 00851861007260 - Respire Pink AT Hard: 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
• 00851861007277 - Respire Pink AT Hard/Soft: 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
• 00851861007000 - Blue Series - H/S: 2020-02-17 Respire Blue Series (Hard/Soft)
• 00851861007017 - Blue Series - Hard: 2020-02-17 Respire Blue Series - Hard
• 00851861007024 - Blue Series - EF: 2020-02-17 Respire Blue Series EF
• 00851861007031 - Pink Micro - Hard: 2020-02-17 Respire Pink (Herbst) Micro - Hard
• 00851861007048 - Pink Micro - H/S: 2020-02-17 Respire Pink Micro (Herbst) Hard/Soft