Duns Number:504406273
Catalog Number
-
Brand Name
Respiratory Humidifier Mounting Accessory C-Clamp Suitable For 19-4.0mm Pole
Version/Model Number
FL2000-02U
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
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
f645336e-aca1-49d3-a90c-f030ae7550f0
Public Version Date
April 16, 2019
Public Version Number
1
DI Record Publish Date
April 08, 2019
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 | 715 |
2 | A medical device with a moderate to high risk that requires special controls. | 465 |