Pink Series - H/S - Intraoral appliance indicated to treat mild to - RESPIRE MEDICAL HOLDINGS LLC

Duns Number:059636679

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

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More Product Details

Catalog Number

-

Brand Name

Pink Series - H/S

Version/Model Number

SP020US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131138

Product Code Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

62187864-c663-44a9-a823-3d286ea71e7e

Public Version Date

February 17, 2020

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRE MEDICAL HOLDINGS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28