Beyond Sleep

Primary DI
10667560060478
Brand
Beyond Sleep
Company
KOBAYASHI CONSUMER PRODUCTS, LLC
Model
667560060471
Device description
Anti-Snoring Strips
Published
2020-07-01
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
10667560060478PackageGS136In Commercial Distribution
00667560060471PrimaryGS10
60667560060473Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066756006047810667560060478
00667560060471006675600604716675600604710667560060471
6066756006047360667560060473

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(800)432-6329kcpinfo@kobayashi.com

Regulatory Flags#

DUNS number
618672760
Device count
21
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667560800138HotHands Therapy6675608001382023-12-01
10667560800135HotHands Therapy6675608001382023-12-01
00667560001009BeKoool6675600010092020-07-01
00667560060471Beyond Sleep6675600604712020-07-01
00667560060501BeKoool6675600605012020-07-01
00667560060563BeKoool6675600605632021-01-26
10667560060560BeKoool6675600605632021-01-26
00667560011008Cura Heat6675600110082020-09-01
00667560011039Cura Heat6675600110392020-09-01
10667560011005Cura Heat6675600110082020-09-01
10667560011036Cura Heat6675600110392020-09-01
00667560002006BeKoool6675600020062020-07-01
00667560005007BeKoool6675600050072020-07-01
00667560060518BeKoool6675600605182020-07-01
10067560001004BeKoool6675600010092020-07-01
10667560002003BeKoool6675600020062020-07-01
10667560005004BeKoool6675600050072020-07-01
10667560060508BeKoool6675600605012020-07-01
10667560060515BeKoool6675600605182020-07-01

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