Duns Number:659177273
Device Description: A long stiffening wire/rod designed for insertion within the lumen of an artificial airway A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g. endotracheal tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation).
Catalog Number
701009
Brand Name
APA™ Stylet
Version/Model Number
701009
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
-
Product Code
BSR
Product Code Name
Stylet, Tracheal Tube
Public Device Record Key
77ef9731-2006-40c2-a2af-444e6268d254
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 25, 2019
Package DI Number
18885009190193
Quantity per Package
10
Contains DI Package
08885009190196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |