AccessGUDID - DEVICE: Provox® NID™ (07331791000294)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® NID™
Version or Model: 17 Fr
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7103
Company Name: Atos Medical AB

Primary DI Number: 07331791000294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
44412	Tracheoesophageal speech valve, non-indwelling	A non-sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy, following wound healing, to provide the patient with voice restoration. It is placed by the trained patient into the fistula. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The user removes this device periodically for cleaning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWL	Prosthesis, Laryngeal (Taub)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043138	000

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
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Millimeter

Device Record Status

Public Device Record Key: 7d71145a-0c49-4d5a-88b8-14373053b2c1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 11, 2016