FDA.reportPublic FDA data

CVS Health

Primary DI
00050428308615
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
542630
Device description
Extra Strength Nasal Strips, Clear Strips
Published
2019-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWFDilator, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWFDilator, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20005042830862PackageGS136Not in Commercial Distribution
00050428308615PrimaryGS10
60050428308617Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2000504283086220005042830862
00050428308615000504283086150504283086150050428308615
6005042830861760050428308617

GMDN Terms#

Term, Definition table
TermDefinition
Nasal breathing aid, externalAn external device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. The device typically consists of an adhesive bandage with two parallel elastic strips placed on the bridge of the nose; it acts with an upward pulling force to flare the nostrils and open the nares. It provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a single-use device.

Regulatory Flags#

DUNS number
062312574
Device count
26
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428344095CVS Health4448302026-10-16
00050428034712CVS Health4820172026-10-10
00050428034743CVS Health7312312026-10-10
00050428142349CVS Health7312302026-10-10
00050428142677CVS Health3765472026-10-10
00050428143117CVS Health5516602026-10-10
00050428143124CVS Health5518142026-10-10
00050428339763CVS Health9356852026-10-10
00050428340523CVS Health4820192026-10-10
00050428340936CVS Health3758122026-10-10
00050428341308CVS Health4885982026-10-10
00050428341728CVS Health2100112026-10-10
00050428342053CVS Health4091722026-10-10
00050428342121CVS Health8759562026-10-10
00050428342602CVS Health4448432026-10-10
00050428343869CVS Health8931252026-10-10
00050428346396CVS Health8759502026-10-10
00050428347133CVS Health3835052026-10-10
00050428143315CVSCVS489905V22026-09-18
00050428340561CVSCVS469682V22026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878321587iNAPSOMNICS, INC.LWF2026-09-21
00850040983111WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983128WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983135WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983142WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00833224009005ZValvesProject SnoreLWF2026-02-20
00833224009012ZValvesProject SnoreLWF2026-02-20
00833224009029ZValvesProject SnoreLWF2026-02-20
00833224009036ZValvesProject SnoreLWF2026-02-20
00833224009043ZValvesProject SnoreLWF2026-02-20
00833224009050ZValvesProject SnoreLWF2026-02-20
00833224009111ZValvesProject SnoreLWF2026-02-20
00833224009128ZValvesProject SnoreLWF2026-02-20
00833224009135ZValvesProject SnoreLWF2026-02-20
00833224009142ZValvesProject SnoreLWF2026-02-20
00833224009159ZValvesProject SnoreLWF2026-02-20
00860014485213BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485237BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485206BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485220BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485244BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485268BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
04719878321525iNAPSOMNICS, INC.LWF2024-02-05
04719878321532iNAPSOMNICS, INC.LWF2024-02-05
00810002220210OASYS (Oral/Nasal Airway System)JOHN'S DENTAL LABORATORY INCLWF2023-03-28
04719878321082SomnicsSOMNICS, INC.LWF2023-03-06
04719878321044SomnicsSOMNICS, INC.LWF2023-02-12
04719878320832SomnicsSOMNICS, INC.LWF2022-11-23
04719878320849SomnicsSOMNICS, INC.LWF2022-11-23
06970757000025YUANRUNBENCAOHebei Yuanrun Medical Devices Co., Ltd.LWF2022-11-01