Duns Number:625064352
Device Description: RAPIDPORT EZ Access Port Kit 14CC
Catalog Number
B-2306
Brand Name
Access Port RapidPort EZ Kit
Version/Model Number
B-2306
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
LTI
Product Code Name
Implant, Intragastric For Morbid Obesity
Public Device Record Key
8c589757-4744-4e74-8a05-347e1ec483c1
Public Version Date
December 30, 2021
Public Version Number
3
DI Record Publish Date
August 26, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 34 |