FDA.reportPublic FDA data

Meijer

Primary DI
00651080000017
Brand
Meijer
Company
MEIJER, INC.
Model
1C4
Device description
SNORE NO MORE 1CT
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10651080000014PackageGS13In Commercial Distribution
20651080000011PackageGS14In Commercial Distribution
00651080000017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065108000001410651080000014
2065108000001120651080000011
00651080000017006510800000176510800000170651080000017

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA 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
006959555
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00719283515964meijer71928351596443238042019-07-30
00713733293129MEIJERMJFAK150V2MJFAK150V22026-04-20
00760236195603MeijerMJFAKMINIMJFAKMINI2026-04-20
00760236195771Meijer20002290N/A2026-04-01
00760236195818Meijer20002291N/A2026-04-01
00760236264811Meijer Advanced One Step Pregnancy Test2020-10-02
00760236264828Meijer Advanced Early Result Pregnancy Test2020-10-02
00760236471646Meijer Saline Wound Wash 95-50740-200-002026-03-06
00719283501233Meijer74-9713487072020-12-07
00719283501288Meijer74-9732020-12-07
00719283338334Meijer Hot & Cold Compression Migraine Mask7192833383342024-04-03
00708820957367Meijer, instant cold pack, value pack 36501102021-02-04
00708820957473Meijer, instant cold pack 36501092020-07-21
00708820519541Meijer Hot/Cold Back Pad34572442017-08-01
00708820519558Meijer Hot & Cold Wrap Ultra-Forming 34572462017-08-01
00708820523418Meijer Hot & Cold Therapy Wrap with Clay Based Technology34583982017-08-01
00708820523425Meijer Hot & Cold Beads Compress with Strap34583972017-08-01
00708820523432Meijer Moist Heat Neck Wrap34583962017-08-01
00760236195696Meijer57005082025-12-24
00760236195702Meijer57005242025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
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00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652110Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652127Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00850085577009Serena Fixed HingeSERENA SLEEP SOLUTIONS LLCLRK2026-03-30
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25