Duns Number:008124539
Device Description: IV Pole - 4 hook and base
Catalog Number
-
Brand Name
IV Pole
Version/Model Number
10555-4HB
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
FOX
Product Code Name
Stand, Infusion
Public Device Record Key
a553e1df-2d0d-471b-a3d2-b30fe12ebfcd
Public Version Date
March 02, 2020
Public Version Number
1
DI Record Publish Date
February 21, 2020
Package DI Number
00840117302648
Quantity per Package
4
Contains DI Package
00840117302631
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |