FDA.reportPublic FDA data

Quality Choice

Primary DI
00635515998544
Brand
Quality Choice
Company
CHAIN DRUG MARKETING ASSOCIATION, INC.
Model
635515998544
Device description
Drug Free Nasal Strips, Tan Extra Strength
Published
2021-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10635515998541PackageGS136In Commercial Distribution
00635515998544PrimaryGS10
60635515998546Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063551599854110635515998541
00635515998544006355159985446355159985440635515998544
6063551599854660635515998546

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.

Contacts#

Phone, Email table
PhoneEmail
800-935-2362xx@xx.xx

Regulatory Flags#

DUNS number
011920774
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
00635515998537Quality Choice6355159985372021-08-09
00635515947443QUALITY CHOICE89-352QC-947442017-02-15
00635515958920QUALITY CHOICE89-362QC-958922017-02-15
00635515986701QUALITY CHOICE89-375QC-986702017-02-15
00635515992207QUALITY CHOICE89-355QC-992202017-02-15
00635515986794QUALITY CHOICE89-50KQC-986792017-02-15
00635515900486Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515956643Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515900493Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515970717Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515959347Quality Choice AutoletAT 0274QC2023-02-03
00761059276333Quality Choice AutoletAT 0274QC2023-02-03
00635515959354Quality Choice UniletAT 0575QC2023-01-26
00635515959361Quality Choice UniletAT 0565QC2023-01-26
00635515994775Quality Choice UniletAT 0585QC2023-01-26
00635515966130Quality ChoiceQC-96613QC-966132022-06-16
10635515966137Quality ChoiceQC-96613QC-966132022-06-16
00635515958838Quality choice TamponsBQCGR202016-09-20
00635515958845Quality choice TamponsBQCGS182016-09-20
00635515958852Quality choice TamponsBQCGP182016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00033732023016AirmaxMcKeon Products, Inc.LWF2022-10-07