Duns Number:141668116
Device Description: Humidifier Connector with Tube (1/pack). Compatible with most continuous flow oxygen conce
Catalog Number
HUM008
Brand Name
Humidifier Connector with Tube
Version/Model Number
HUM008
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
fcdef645-4af7-408f-82b0-9ae534771887
Public Version Date
August 29, 2018
Public Version Number
1
DI Record Publish Date
July 29, 2018
Package DI Number
10848530089822
Quantity per Package
10
Contains DI Package
00848530089825
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |