FDA.report

CVS Health

Primary DI
20005042830862
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LWFDilator, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
LWFDilator, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20005042830862PackageGS136In Commercial Distribution
00050428308615PrimaryGS10
60050428308617Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2000504283086220005042830862
00050428308615000504283086150504283086150050428308615
6005042830861760050428308617

GMDN Terms

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

Regulatory Flags

DUNS number
062312574
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

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