FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Respire Pink+ Hard with DentiTrac
DI: 00851861007222
·
Model: SPPD000US
·
RESPIRE MEDICAL HOLDINGS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Respire Pink+ Hard with DentiTrac
- Primary DI
- 00851861007222
- Version / Model
- SPPD000US
- Company Name
- RESPIRE MEDICAL HOLDINGS LLC
- Labeler DUNS
- 059636679
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 6
- Public Version Date
- 2020-02-17
- Public Version Status
- Update
- Public Device Record Key
- 91ecdf98-bb95-4540-aafa-54b4632f371f
- Distribution End Date
- 2018-05-23
Device Description
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLC | Sleep Appliances With Patient Monitoring | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47526 | Mandible-repositioning sleep-disordered breathing orthosis | A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851861007222 | GS1 |
Customer Contacts
- Phone
- 7187437326
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170692 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 200 | Millimeter |