Duns Number:008124539
Device Description: IV Pole Kit with Enteral Feeding Syringe (60cc), Non-Sterile
Catalog Number
-
Brand Name
IV Pole Kit
Version/Model Number
4265
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
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
cee2545f-081a-40ce-bb74-aa99e640475d
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784426532
Quantity per Package
30
Contains DI Package
00616784426518
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 |