FDA.reportPublic FDA data

Lunoa

Primary DI
08719689344511
Brand
Lunoa
Company
NightBalance Holding B.V.
Model
L1CHST01
Catalog number
L1CHST01
Device description
Lunoa Chest Strap
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYBPillow, cervical (for mild sleep apnea)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYBPillow, Cervical (For Mild Sleep Apnea)Dental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180608000Lunoa SystemNightbalance BV2018-06-05MYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719689344030Direct MarkingGS10
08719689344511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689344030087196893440308719689344030
08719689344511087196893445118719689344511

GMDN Terms#

Term, Definition table
TermDefinition
Sleep apnoea bed pillowA specially designed cushion intended to support the head and neck (the cervical region) in a position that is similar to that used in cardiopulmonary resuscitation (CPR), so that the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnoea. It may also be used to help reduce snoring and improve the quality of sleep. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
489925212
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719689344504LunoaL1US01USL1US01US2018-08-20
08719689344092LunoaL1US01USL1US01US2018-08-20
08719689344030LunoaL1CHST01L1CHST012018-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034296Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034319Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034326Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034333Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034357Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034340Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-11-14
70850015266194Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-10-27
00850063034302Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-08-21
00850063034272Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034289Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034265Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-05-22
10850015266192Night ShiftADVANCED BRAIN MONITORING, INC.MYB2024-03-14
00850015266492Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266508Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266515Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266195Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266218Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266232Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
20850015266199Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
30850015266196Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
40850015266193Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
50850015266190Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
60850015266197Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
80850015266191Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00606959054615NightBalanceRespironics, Inc.MYB2020-12-15
00606959054639NightBalanceRespironics, Inc.MYB2020-12-15
30606959054616NightBalanceRespironics, Inc.MYB2020-12-15
30606959054630NightBalanceRespironics, Inc.MYB2020-12-15
00850015266072Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30
00850015266089Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30