Duns Number:529125266
Device Description: Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 8.0
Catalog Number
ETT-X22-80
Brand Name
Medis
Version/Model Number
ETT-X22-80
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"
Yes
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
K190274,K190274,K190274
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
c31c772f-5ee2-4bef-bf2c-6511cde2ab96
Public Version Date
May 19, 2020
Public Version Number
1
DI Record Publish Date
May 11, 2020
Package DI Number
16920687303632
Quantity per Package
10
Contains DI Package
06920687303635
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box