Duns Number:355470923
Device Description: Freevent HME 15 is a Heat and Moisture Exchanger (HME) intended for spontaneously breathin 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.
Catalog Number
7742
Brand Name
Freevent HME
Version/Model Number
15 Regular
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151404,K151404,K151404
Product Code
JOH
Product Code Name
Tube Tracheostomy And Tube Cuff
Public Device Record Key
aeb98928-3ae7-4aa6-a0ef-f5c9258b3490
Public Version Date
July 18, 2022
Public Version Number
3
DI Record Publish Date
May 29, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |