Duns Number:514824387
Device Description: AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while p AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.
Catalog Number
HSAG100S01
Brand Name
AG100s control unit
Version/Model Number
AG100s control unit
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
d6c06282-7b6e-4a42-af1f-6a621a734ea8
Public Version Date
April 03, 2019
Public Version Number
2
DI Record Publish Date
March 23, 2019
Package DI Number
17290015409107
Quantity per Package
1
Contains DI Package
07290015409100
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 |