FDA.reportPublic FDA data

Equaline

Primary DI
10041163498508
Brand
Equaline
Company
SUPERVALU INC.
Model
041163498501
Device description
Clear Drug Free Extra Strength Nasal Strips
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10041163498508PackageGS136In Commercial Distribution
00041163498501PrimaryGS10
60041163498503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004116349850810041163498508
00041163498501000411634985010411634985010041163498501
6004116349850360041163498503

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18779327948xx@xx.xx
855-423-2630xx@xx.xx

Regulatory Flags#

DUNS number
006961411
Device count
26
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041163500648Equaline0411635006482020-05-29
00041163498174EqualineALB4145ALB41452025-10-09
00041163250925Equaline7W926ELC22022-10-11
00041163503885EqualineKD-20502023-09-05
20041163503889EqualineKD-20502023-09-05
10041163250922Equaline7W926ELC22022-10-11
00041163263352Equaline TamponsBSVAR402016-09-20
00041163263369Equaline TamponsBSVAS402016-09-20
00041163263383Equaline TamponsBSVAC402016-09-20
00041163444164Equaline TamponsBSVGC362016-09-20
00041163471559Equaline TamponsBSVGS182016-09-20
00041163497306Equaline TamponsBSVUR182016-09-20
00041163497313Equaline TamponsBSVUS182016-09-20
00041163497344Equaline TamponsBSVGS362016-09-20
00041163497368Equaline TamponsBSVGR362016-09-20
00041163497375Equaline TamponsBSVGR182016-09-20
00041163499133Equaline TamponsBSVXR182017-05-02
00041163499140Equaline TamponsBSVXS182017-05-02
00041163499157Equaline TamponsBSVXC182017-05-02
00041163450240Equaline0411634502402020-05-29

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