Duns Number:053146767
Device Description: ACU 1060.1 Transtracheal Catheter provides tracheal access for manual jet ventilators. Th ACU 1060.1 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration. Needle size: 13Gauge / Adult RX only.
Catalog Number
ACU 1060.1
Brand Name
ACU 1060.1 Transtracheal Catheter
Version/Model Number
ACU 1060.1
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
K955461
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
8aeac706-4a19-47b6-97c7-339f9aeba519
Public Version Date
January 21, 2021
Public Version Number
1
DI Record Publish Date
January 13, 2021
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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |