Catalog Number
-
Brand Name
Nasal Jet Tube
Version/Model Number
A06A067010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K211543,K211543,K211543
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
4cddb740-1ee2-4955-803c-581658f54e54
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
Package DI Number
16944932776262
Quantity per Package
10
Contains DI Package
06944932776265
Package Discontinue Date
-
Package Status
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 |