Duns Number:092673953
Device Description: Inline Water Trap, For Oxygen Delivery(This is a component of the Composite Kit for Nation Inline Water Trap, For Oxygen Delivery(This is a component of the Composite Kit for Nationwide Home Med - Part #0837)
Catalog Number
-
Brand Name
Inline Water Trap
Version/Model Number
0221B
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
K954271
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
d0d26c6d-aad4-4fcc-823e-d06451c580cd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 19, 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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |