AccessGUDID - DEVICE: Keenhealth (08719699632714)

GUDID

Device Identifier (DI) Information

Brand Name: Keenhealth
Version or Model: K-NS-356-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sevenground Trading B.V.

Primary DI Number: 08719699632714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 492177197 *Terms of Use

Device Description: K-NS-356-60 is a better breath Stop Snoring Nasal Strips

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47606	Nasal breathing aid, external	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	Fiber, Medical, Absorbent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 17ba1f94-7e0b-4286-baa6-2df1e1c3d4fe
Public Version Date: October 30, 2019
Public Version Number: 2
DI Record Publish Date: September 20, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 08719699633629 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES