Duns Number:324869601
Device Description: Quicktrach II Emergency Cricothyrotomy Set for adult
Catalog Number
-
Brand Name
N/A
Version/Model Number
30-10-904-1
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"
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
K874742,K874742,K874742
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
fe253bf2-8a75-411f-9626-4ad3edba5f28
Public Version Date
October 25, 2019
Public Version Number
4
DI Record Publish Date
March 16, 2016
Package DI Number
14250105612452
Quantity per Package
1
Contains DI Package
04250105612455
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |