Duns Number:306032491
Device Description: Single use injection port for subcutaneous injection. The injection port must be used as d Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
Catalog Number
-
Brand Name
i-port ADVANCE™
Version/Model Number
MMT-101
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
FOZ
Product Code Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Public Device Record Key
4ab78efa-856d-46b2-aac2-142588a072cb
Public Version Date
January 11, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
05705244009424
Quantity per Package
100
Contains DI Package
05705244009417
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |