Duns Number:600248533
Device Description: The Cuffix is intended to measure and regulate, through passive control, intracuff pressur The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.
Catalog Number
-
Brand Name
Cuffix
Version/Model Number
01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 03, 2021
Issuing Agency
In GS1
MRI safety Status
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)
-
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
K192611,K192611
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
ea63f8db-f360-41a7-9a4c-f278c587311c
Public Version Date
January 04, 2021
Public Version Number
2
DI Record Publish Date
December 24, 2020
Package DI Number
17290017345014
Quantity per Package
5
Contains DI Package
07290017345017
Package Discontinue Date
January 03, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |