AccessGUDID - DEVICE: Freevent HME 15 Regular (07331791015069)

GUDID

Device Identifier (DI) Information

Brand Name: Freevent HME 15 Regular
Version or Model: 7742
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7742
Company Name: Atos Medical AB

Primary DI Number: 07331791015069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 355470923 *Terms of Use
Previous DI: 07331791008207

Device Description: Freevent HME 15 is a Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a ISO 15 mm connector. The HME conditions inhaled air by retaining heat and moisture from the exhaled air. The device also partially restores lost breathing resistance.

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:	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?
58705	Tracheostoma protective filter	A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.	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: aeb98928-3ae7-4aa6-a0ef-f5c9258b3490
Public Version Date: November 25, 2024
Public Version Number: 6
DI Record Publish Date: May 29, 2020