Respire Pink AT EF

GUDID 00851861007253

Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

RESPIRE MEDICAL HOLDINGS LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851861007253
• NIH Device Record Key: 99fc4af5-1454-4c61-b82b-7b65797d0da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respire Pink AT EF
• Version Model Number: SPAT030US
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00851861007253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192127

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: 2020-02-21
• Device Publish Date: 2020-02-13

Devices Manufactured by RESPIRE MEDICAL HOLDINGS LLC

• 00851861007253 - Respire Pink AT EF: 2020-02-21Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
• 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