Duns Number:092673953
Device Description: 60` 28V Adult Htd Limb, St Water, 40 CM Pop Off Valve, 15`
Catalog Number
-
Brand Name
Heated circuit
Version/Model Number
9411
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
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
8c7df8c2-1404-49b2-9c72-1f20bb0012dc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 20, 2017
Package DI Number
10709078001151
Quantity per Package
18
Contains DI Package
00709078001154
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 |