Easy Breathe

Primary DI
20850000495238
Brand
Easy Breathe
Company
Aso LLC
Model
850000495234
Device description
Sleep Strips, tan strips
Published
2020-04-29
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
20850000495238PackageGS136In Commercial Distribution
00850000495234PrimaryGS10
60850000495236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000049523820850000495238
00850000495234008500004952348500004952340850000495234
6085000049523660850000495236

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
1-855-823-4545xx@xx.xx

Regulatory Flags#

DUNS number
152793493
Device count
6
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
false
Sterilization required before use
false

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