Duns Number:514824387
Device Description: The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways.
Catalog Number
HSCUFF0041
Brand Name
AG Cuffill (cmH2O)
Version/Model Number
HSCUFF0041
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K122721,K122721,K122721
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
0bcbf51d-bb17-4af1-8e3e-b457e2e24ab1
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
27290015409005
Quantity per Package
200
Contains DI Package
17290015409008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |