Duns Number:117070072
Device Description: Non-coring (Huber) needle for use with Intera Infusion Pumps, Straight, 22 Gauge, 1 inch
Catalog Number
AP04009
Brand Name
INTERA
Version/Model Number
AP-04009
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
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
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
5d089c25-0220-45d1-b903-6783f81800d0
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
10850014110014
Quantity per Package
15
Contains DI Package
00850014110017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 3 |