Duns Number:053146767
Device Description: KC 048-5N - 48" length, 10mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single KC 048-5N - 48" length, 10mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
Catalog Number
-
Brand Name
KC 048-5N 10mm ID Ventilator Tubing with Integral Cuffs
Version/Model Number
KC 048-5N
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
6335f60d-b1c2-41ec-a2ee-3e5b28dbc4b2
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
April 14, 2017
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 |