Respire Pink EF+ with DentiTrac

GUDID 00851861007246

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

RESPIRE MEDICAL HOLDINGS LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851861007246
• NIH Device Record Key: a7da70a9-0c5c-4c0a-84a0-df6a9ff8d506
• Commercial Distribution Discontinuation: 2018-05-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Respire Pink EF+ with DentiTrac
• Version Model Number: SPPD030US
• Company DUNS: 059636679
• Company Name: RESPIRE MEDICAL HOLDINGS LLC
• 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: 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: 7186437326
• Email: info@respiremedical.com

Device Dimensions

• Circumference: 200 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851861007246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170692

FDA Product Code

• PLC: Sleep Appliances With Patient Monitoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-17
• Device Publish Date: 2017-09-15

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