Duns Number:118492643
Device Description: Contains the following items:(1) Disposable Scalpel #10 Blade(1) 6.0 ID Airway with Cuff a Contains the following items:(1) Disposable Scalpel #10 Blade(1) 6.0 ID Airway with Cuff and Flange(1) 10cc Transparent Syringe(1) News Tracheal Hook(1) Trach Tube Holder
Catalog Number
HHSCK01-EA
Brand Name
Simplified Cricothyrotomy Kit
Version/Model Number
02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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
-
Product Code
OGP
Product Code Name
Cricothyrotomy Kit
Public Device Record Key
72f08696-ad28-4038-bf24-8d28a68349bf
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |