Duns Number:053146767
Device Description: KC 042-N, 10mm ID, 42" length - Reusable Ventilator Tubing - polyester elastomer tube wit KC 042-N, 10mm ID, 42" length - Reusable Ventilator Tubing - polyester elastomer tube with silicone rubber cuffs
Catalog Number
-
Brand Name
KC 042-N - 10mm ID Reusable Ventilator Tubing
Version/Model Number
KC 042-N
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
-
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
e02de0e6-dd40-4762-9a40-6ad54f6d54a2
Public Version Date
December 11, 2019
Public Version Number
3
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 |