Duns Number:514824387
Device Description: The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal int The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
Catalog Number
ETP75PUC1
Brand Name
AnapnoGuard™ Endotracheal Tube 7.5mm
Version/Model Number
AnapnoGuard™ Endotracheal Tube 7.5mm
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093126,K093126,K093126
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
5f44e11a-c27d-4965-892c-47862e7258ec
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
March 05, 2019
Package DI Number
27290015409159
Quantity per Package
100
Contains DI Package
17290015409152
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 |