Duns Number:053146767
Device Description: Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheost Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient.
Catalog Number
BE 409
Brand Name
Pilot Tube Repair Kit
Version/Model Number
BE 409
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
655a4a83-e7cc-452c-9015-7de492edfd78
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 31, 2015
Package DI Number
M996BE4092
Quantity per Package
10
Contains DI Package
M996BE4090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
ziplock bag
| 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 |