Duns Number:249675476
Device Description: It's a stand which is equipped of 2 hanging hooks.
Catalog Number
FA64523-TRI
Brand Name
IV Pole
Version/Model Number
FA64523-TRI
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
2b53328c-13a2-4ac2-8757-f86532915978
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
Package DI Number
10670482000583
Quantity per Package
1
Contains DI Package
00670482000586
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |