AccessGUDID - DEVICE: Meniett ® Pulse Generator- LOANER (05708265010059)

GUDID

Device Identifier (DI) Information

Brand Name: Meniett ® Pulse Generator- LOANER
Version or Model: MT-GEN-LO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-GEN-LO
Company Name: Lina Medical ApS

Primary DI Number: 05708265010059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305088619 *Terms of Use

Device Description: No description.

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):	Yes
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?
47542	Middle ear decompressor, positive pressure	A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETY	Tester, Auditory Impedance

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 6dd4276a-db16-4775-874e-b75e8601967e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 30, 2016