AccessGUDID - DEVICE: Freevent DualCare Set 15 (07331791015021)

GUDID

Device Identifier (DI) Information

Brand Name: Freevent DualCare Set 15
Version or Model: 7741
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7741
Company Name: Atos Medical AB

Primary DI Number: 07331791015021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use
Previous DI: 07331791008191

Device Description: Freevent DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the speaking valve into speaking mode air is re-directed to enable speech.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOH	Tube Tracheostomy And Tube Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151404	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
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 15 Millimeter

Device Record Status

Public Device Record Key: 8a97d197-4f48-4e9b-b6aa-1b067c88be99
Public Version Date: November 25, 2024
Public Version Number: 6
DI Record Publish Date: May 29, 2020