Duns Number:131480662
Device Description: The TacMed™ Surgical Airway Kit provides the essential items to successfully establish and The TacMed™ Surgical Airway Kit provides the essential items to successfully establish and secure a surgical airway in any environment. All of the necessary components are neatly vacuum-packed for easy storage and maximum accessibility. Standard Contents: 1x Tracheostomy Tube Cuffed size 6.0MM 1x #10 Disposable Scalpel 1x 3CC Syringe 1x Serpent Hook 1x Alcohol Pads 1PR Nitrile Gloves
Catalog Number
TSAK-HC
Brand Name
TacMed™ Surgical Airway Ki
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OGP
Product Code Name
Cricothyrotomy Kit
Public Device Record Key
ae359393-1ca0-4e58-b5ab-5f2dd9b63af8
Public Version Date
November 16, 2020
Public Version Number
1
DI Record Publish Date
November 06, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |