Home GUDID 00850077473012 EMA Serena Patient Starter kits
Primary DI 00850077473012
Brand EMA Serena Patient Starter kits
Company EMA SLEEP INCORPORATED
Model EMA SERENA
Catalog number EMAST6B
Device description An elastic intra-oral appliance strap used with mandibular advancement devices to adjust and maintain lower jaw positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.
Published 2026-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LRK Device, Anti-Snoring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRK Device, Anti-Snoring Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850077473012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850077473012 00850077473012 850077473012 0850077473012
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 100648767 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850077473005 EMA NOW PATIENT STARTER KITS EMA NOW EMAST12Y 2026-08-14 00850077473029 EMA 3D PATIENT STARTER KITS EMA 3D EMAST10B 2026-08-14 00850077473043 INDIVIDUAL EMA STRAPS(EMAST13W) EMA 13 WHITE EMAST13W 2026-08-14 00850077473050 Individual EMA Straps(EMAST14W) EMA 14 WHITE EMAST14W 2026-08-14 00850077473067 Individual EMA Straps(EMAST15W) EMA 15 WHITE EMAST15W 2026-08-14 00850077473074 Individual EMA Straps(EMAST16W) EMA 16 WHITE EMAST16W 2026-08-14 00850077473081 Individual EMA Straps(EMAST17W) EMA 17 WHITE EMAST17W 2026-08-14 00850077473098 Individual EMA Straps(EMAST18W) EMA 18 WHITE EMAST18W 2026-08-14 00850077473104 Individual EMA Straps(EMAST19W) EMA 19 WHITE EMAST19W 2026-08-14 00850077473111 Individual EMA Straps(EMAST20W) EMA 20 WHITE EMAST20W 2026-08-14 00850077473128 Individual EMA Straps(EMAST21W) EMA 21 WHITE EMAST21W 2026-08-14 00850077473135 Individual EMA Straps(EMAST13Y) EMA 13 YELLOW EMAST13Y 2026-08-14 00850077473142 Individual EMA Straps(EMAST14Y) EMA 14 YELLOW EMAST14Y 2026-08-14 00850077473159 Individual EMA Straps(EMAST15Y) EMA 15 YELLOW EMAST15Y 2026-08-14 00850077473166 Individual EMA Straps(EMAST16Y) EMA 16 YELLOW EMAST16Y 2026-08-14 00850077473173 Individual EMA Straps(EMAST17Y) EMA 17 YELLOW EMAST17Y 2026-08-14 00850077473180 Individual EMA Straps(EMAST18Y) EMA 18 YELLOW EMAST18Y 2026-08-14 00850077473197 Individual EMA Straps(EMAST19Y) EMA 19 YELLOW EMAST19Y 2026-08-14 00850077473203 Individual EMA Straps(EMAST20Y) EMA 20 YELLOW EMAST20Y 2026-08-14 00850077473210 Individual EMA Straps(EMAST21Y) EMA 21 YELLOW EMAST21Y 2026-08-14
Other Devices Sharing Product Codes# 
ema-sleep.com