Duns Number:092673953
Device Description: Composite Kit, High Flow Humidifier, Adult Cannula, 14' Tubing
Catalog Number
-
Brand Name
Composite Kit
Version/Model Number
0793
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
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
6857ed37-20be-4202-9921-2bf639ff925f
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2017
Package DI Number
10709078003025
Quantity per Package
10
Contains DI Package
00709078003028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |