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Respire Pink+ H/S with DentiTrac

FDA UDI

Class II (US FDA UDI)

by Respire Medical Holdings

Identity

Trade Name
Respire Pink+ H/S with DentiTrac FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring. FDA UDI
Model / Reference
SPPD020US FDA UDI
Description
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring. FDA UDI

Identifiers

Primary DI / UDI-DI
00851861007239 FDA UDI
510(k) Number
K170692 FDA UDI
FDA Product Code
PLC FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Circumference — 200 Millimeter FDA UDI

Respire Pink+ H/S with DentiTrac by Respire Medical Holdings — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K170692 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respire Medical Holdings

Sources (1)

  • FDA UDI 35a40f3a-6eb3-4559-b081-34cf8ec9283b 37 fields · synced May 30, 2026